Ultrasound System

Model Number 10041461-ACUSON S2000. Serial numbers to follow

Radiology Devices

2

No

Worldwide Distribution including USA, states of AZ, VA, CA, NE, IL, MN, TN, FL, NM, and DC

ACUSON S2000 ultrasound system || Manufactured by Siemens Medical Solutions USA, Inc. || Business Unit Ultrasound, || 1230 Shorebird Way || Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications.

Serial Numbers Affected: 250171, 250173, 250177, 250157, 250162, 250163, 250164, 250166, 250167 and 250169

Radiology Devices

2

No

Worldwide Distribution - USA, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia.

Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; || Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); (2) 10434969, Arm Welding (for S/N's 250171, 250173, 250177); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA || The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers.

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Radiology Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Malaysia, Netherlands, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

TRACE ITEM SERIAL NUMBERS in the UNITED STATES: US713B0171, US713B0207, US813B0017, US813B0018, US813B0019, US813B0020, US813B0022, US813B0023, US813B0024, US813B0025, US813B0122, US813B0123, US813B0125, US813B0127, US813B0128, US813B0129, US813B0131, US813B0132, US813B0134, US813B0135, US813B0233, US813B0234, US813B0235, US813B0236, US813B0237, US813B0238, US813B0239, US813B0240, US813B0423, US813B0424, US813B0425, US813B0426, US813B0427, US813B0428, US813B0429, US813B0430, US813B0431, US813B0432, US813B0433, US813B0434, US913B0033, US913B0034, US913B0035, US913B0036, US913B0037, US913B0038, US913B0039, US913B0040, US913B0057, US913B0060, US913B0061, US913B0062, US913B0063, US913B0064, US913B0065, US913B0066, US913B0106, US913B0107, US913B0108, US913B0109, US913B0110, US913B0111, US913B0112, US913B0113, US913B0144, US913B0176, US913B0201, US913B0256, US913B0257, US913B0350, US913B0363, US913B0364, US913B0365, US913B0366, US913B0367, US913B0368, US913B0369, US913B0380, US913B0384, US913B0395, US913B0396, US913B0397, US913B0398, US913B0399, US913B0400, US913B0401, US913B0402, US913B0409, US913B0441, US913B0444, US913B0445, US913B0446, US913B0447, US913B0503, US913B0522, US913B0614, US913B0615, US913B0616, US913B0618, US913B0619, and USO13B0043.  TRACE ITEM SERIAL NUMBERS INTERNATIONAL:  US513B0224, US513B0295, US513B0387, US513B0560, US613B0299, US713B0085, US713B0086, US713B0118, US713B0119, US713B0120, US713B0122, US713B0123, US713B0126, US713B0149, US713B0171, US713B0172, US713B0192, US713B0193, US713B0194, US713B0195, US713B0204, US713B0205, US713B0206, US713B0208, US713B0324, US713B0325, US713B0358, US713B0359, US713B0437, US713B0439, US713B0440, US713B0532, US713B0537, US713B0573, US713B0574, US713B0575, US713B0576, US713B0577, US713B0578, US713B0579, US713B0580, US713B0581, US713B0582, US713B0583, US713B0584, US713B0586, US713B0587, US713B0588, US713B0589, US713B0590, US713B0592, US713B0593, US713B0594, US713B0595, US813B0015, US813B0016, US813B0032, US813B0037, US813B0038, US813B0039, US813B0121, US813B0151, US813B0152, US813B0153, US813B0154, US813B0155, US813B0156, US813B0157, US813B0158, US813B0159, US813B0160, US813B0161, US813B0162, US813B0163, US813B0164, US813B0183, US813B0184, US813B0185, US813B0186, US813B0187, US813B0188, US813B0189, US813B0190, US813B0191, US813B0192, US813B0193, US813B0194, US813B0195, US813B0196, US813B0232, US813B0396, US813B0397, US813B0398, US813B0399, US813B0400, US813B0401, US813B0402, US813B0403, US813B0404, US813B0405, US813B0406, US813B0407, US813B0408, US813B0409, US813B0410, US813B0411, US813B0468, US813B0469, US813B0470, US813B0471, US813B0472, US813B0473, US813B0474, US813B0475, US813B0476, US813B0477, US813B0478, US813B0479, US813B0480, US913B0026, US913B0027, US913B0028, US913B0029, US913B0030, US913B0031, US913B0032, US913B0041, US913B0051, US913B0059, US913B0085, US913B0086, US913B0101, US913B0102, US913B0103, US913B0104, US913B0105, US913B0130, US913B0132, US913B0133, US913B0134, US913B0135, US913B0137, US913B0138, US913B0139, US913B0140, US913B0141, US913B0142, US913B0143, US913B0177, US913B0178, US913B0179, US913B0185, US913B0202, US913B0216, US913B0217, US913B0218, US913B0219, US913B0220, US913B0221, US913B0222, US913B0223, US913B0232, US913B0252, US913B0253, US913B0254, US913B0255, US913B0259, US913B0260, US913B0299, US913B0300, US913B0301, US913B0302, US913B0303, US913B0316, US913B0317, US913B0318, US913B0319, US913B0332, US913B0333, US913B0336, US913B0337, US913B0338, US913B0339, US913B0340, US913B0349, US913B0359, US913B0360, US913B0385, US913B0408, US913B0458, US913B0459, US913B0486, US913B0487, US913B0488, US913B0489, US913B0490, US913B0499, US913B0504, US913B0505, US913B0506, US913B0565, US913B0566, US913B0567, US913B0568, USO13B0040, and USO13B0041.

Radiology Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Ireland, Republic of Korea, Latvia, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and United Kingdom.

EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. || Intended for diagnostic ultrasound imaging and fluid flow analysis.

Serial Numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641 400770 401110 401114 401135 401136 401138 401169 401174 401176 401366 401370 401406 401460 401591 401750 401793 401803 402090 402139 402177 402197 402255 402323 402327 402339 402351 402387 402492 402508 402562 402566 400063 400066 400090 400261 400350 400763 400787 400789 400790 400791 400792 400794 400797 400881 400886 400888 400890 400892 400898 401957 402451 400139 400141 400171 400235 400287 400291 400292 400293 400337 400338 400351 400458 400459 400475 400526 400527 400529 400583 400589 400593 400620 400693 400720 400743 400843 400868 400872 400873 400877 400878 400891 400895 400921 400958 400959 400960 400970 400989 401001 401012 401029 401031 401041 401044 401065 401075 401081 401083 401130 401132 401175 401187 401237 401243 401271 401286 401291 401305 401426 401441 401445 401540 401590 401662 401705 401725 401728 401744 401746 401753 401758 401810 401832 401841 401863 401889 401892 401910 401915 401916 401917 401929 401943 401969 402011 402027 402050 402051 402077 402109 402131 402190 402191 402220 402226 402229 402242 402243 402244 402253 402257 402260 402275 402296 402341 402379 402396 402398 402436 402443 402444 402503 402514 402570 402579 400065 400100 400492 400715 400914 401108 401109 401255 401638 401641 401845 402279 400174 400440 400448 400538 400541 400572 400615 400622 400623 400626 400799 400830 400882 400931 401049 401115 401285 401343 401375 401397 401402 401409 401424 401425 401430 401570 401730 401734 401991 402026 401890 401898 401899 401906 400029 400070 400195 400223 400224 400233 400309 400454 400456 400530 400552 400617 400814 400818 400835 401281 401476 401547 401565 401567 401568 401602 401900 401950 401959 401961 402280 402322 402449 400472 401173 401289 401501 401507 401552 401600 401797 401825 401837 402236 402386 400665 400676 400678 400683 400822 400145 400179 400310 400311 400968 401378 401446 400175 400226 400236 400244 400245 400264 400267 400269 400283 400288 400297 400536 400629 400640 400679 400680 400717 400757 400759 400768 400773 400775 400788 400795 400800 400832 400848 400874 400883 400884 400885 400905 400967 400974 401028 401111 401258 401265 401266 401278 401348 401379 401384 401386 401391 401423 401429 401491 401494 401572 401584 401592 401610 401621 401636 401639 401674 401678 401732 401737 401747 401862 401864 401867 401872 401918 401987 402025 402028 402081 402118 402200 402215 402216 402320 402407 402448 402481 400220 400221 400435 400437 400451 400767 400803 400821 400862 400986 401177 401453 401462 401574 401575 401765 402406 402442 402489 401040 400570 401007 401010 401020 401235 401252 401520 401564 401611 401804 401846 402030 402336 402454 402476 402500 402511 402513 401691 401771 402143 402271 402273 402290 402306 402325 400442 400486 400487 400489 400564 400998 400999 401979 402029 400449 401562 401597 401648 402094 400048 400093 400118 400132 400143 400295 400431 401216 400023 400069 400088 400120 400126 400265 400299 400326 400480 400485 400550 400689 400691 400700 400742 400786 400893 400913 400979 401112 401315 401351 401373 401461 401625 401631 402023 402031 402048 402258 402313 402319 402332 402357 402391 402431 402484 400123 400137 400152 400197 400234 400312 400436 400477 400669 400817 400929 400972 401054 401055 401067 401071 401503 401836 402010 402018 402022 402056 402125 402127 402145 402168 402214 402222 402228 402230 402254 402318 402333 402337 402354 402377 402412 402421 402472 402548 400483 400484 400513 400535 400847 400923 400951 400978 401003 401013 401014 401023 401025 401134 401234 401256 401369 401392 401410 401539 401708 402316 402317 402330 402334 402345 402375 402397 402399 401250 401322 401323 401327 401433 401124 401458 401533 401553 401656 401660 402223 400336 400196 400464 400988 401194 401346 401405 401500 401710 401713 401760 401769 401787 401859 401881 401883 401902 402102 402256 402287 402315 401645 401774 402064 402285 402417 402447 402453 400108 400135 400138 400156 400177 400203 400222 400228 400246 400313 400317 400318 400322 400324 400446 400452 400455 400457 400465 400471 400496 400621 400650 400663 400664 400667 400668 400675 400698 400991 401015 401030 401078 401090 401241 401246 401248 401249 401345 401360 401404 401475 401573 401599 401628 401751 401782 401821 401839 401847 401849 401850 401855 401856 401857 401860 401877 402086 402175 402248 402250 402282 402305 402400 402411 402515 402542 402546 400024 400084 400117 400131 400154 400712 400716 400899 400907 400953 400964 401008 401070 401244 401629 401801 401827 402249 400067 400086 400128 400142 400163 400708 400736 400782 400810 400811 400887 400889 401043 401069 401155 401156 401181 401182 401193 401204 401226 401245 401267 401268 401269 401279 401280 401287 401444 401554 401885 401940 402014 402049 402057 402082 402087 402095 402192 402371 402374 402382 402392 402429 400595 400613 400894 400940 400954 400955 400962 401802 402154 400662 400674 400687 400813 401116 401236 401257 401320 401559 401576 402041 402219 400081 400122 400168 400194 400204 400229 400230 400314 400316 400346 400355 400438 400460 400461 400462 400463 400466 400467 400470 400479 400493 400501 400516 400519 400520 400545 400638 400666 400829 400851 400852 400855 400857 400944 400956 400965 400994 400997 401011 401022 401080 401088 401117 401141 401149 401158 401184 401290 401300 401308 401311 401314 401319 401326 401333 401335 401336 401347 401361 401365 401383 401422 401438 401440 401550 401557 401578 401612 401616 401633 401653 401683 401693 401697 401700 401706 401711 401724 401729 401733 401772 401776 401799 401868 401873 401878 401880 401882 401907 401911 401914 401927 402012 402020 402021 402054 402238 402262 402264 402268 402283 402299 402303 402307 402326 402353 402369 402376 402423 402457 402485 402524 402533 402534 402564 402573 402574 400930 401190 400517 400577 400740 401137 401363 401364 401583 400860 400875 400912 400925 400162 400225 400404 400474 400634 400900 400902 400153 400258 400303 400304 400528 400548 400554 400555 400694 400992 401061 401247 401282 401328 401385 401387 401407 401427 401450 401493 401608 401618 401669 401800 401826 401830 401840 401843 401848 401851 401879 401981 402068 402083 402089 402237 402286 402420 402478 402501 402510 401139 400672 401002 401992 402493 402576 402588 400630 400102 400861 400985 401089 401538 401558 401569 401586 401587 401607 401644 402312 402338 402418 400050 400124 400176 400227 400473 400649 401294 401505 401680 401727 401813 402078 402206 402211 402233 402252 402439 402456 402496 402499 401561 401655 402162 400129 400130 400481 400573 400610 400618 400671 400776 400820 401198 401213 401307 401432 401474 401489 401497 401596 401735 401741 401743 401795 401838 401908 401919 401922 402266 402278 402284 402289 402301 402413 402460 402516 402568 401063 401436 400935 400604 401537 400682 401388 400140 400166 400349 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733 400737 400746 400752 400753 400771 400777 400784 400804 400833 400919 400983 401016 401036 401208 401275 401283 401284 401316 401337 401376 401377 401390 401437 401443 401448 401478 401495 401647 401654 401667 401763 401807 401866 401870 402042 402137 402176 402194 402202 402207 402259 402261 402352 402370 402468 402480 402483 402490 400186 400499 400896 401159 401188 401189 401191 401757 401783 402136 402227 402304 402324 402395 401457 401913 401977 401722 400809 402240 401160 401549 400259 402009 400774 401412 402208 400282 400294 400723 400758 400762 400831 401532 401704 401809 400402 400633 401027 401921 401924 401962 402075 402144 402188 400296 400111 400319 401223 401499 401794 401822 401876 401896 402544 400515 400793 400942 401642 401986 402067 402193 402346 401449 400343 400699 401865 402314 401650 400849 401400 400816 401649 402234 401806 402142 402294 400216 401143 400212 400213 400215 400280 400405 400407 400546 400560 400713 400722 400729 400730 400731 400734 400735 400764 400766 400815 400903 400920 400945 401018 401021 401048 401052 401056 401128 401133 401140 401196 401210 401225 401232 401239 401273 401325 401334 401368 401371 401393 401403 401506 401543 401571 401580 401581 401613 401620 401623 401635 401707 401756 401796 401811 401842 401861 401995 402007 402036 402055 402061 402066 402072 402084 402205 402217 402329 402390 402403 402404 402462 402463 402502 401125 400106 400149 400151 400242 400243 400289 400302 400325 400341 400347 400348 400415 400444 400510 400543 400547 400557 400558 400562 400575 400661 400726 400732 400779 400904 400936 400939 400941 400952 400961 400975 400980 400987 400996 401009 401050 401072 401073 401120 401121 401123 401142 401209 401229 401260 401288 401338 401344 401452 401522 401551 401555 401556 401560 401577 401579 401588 401589 401603 401604 401606 401614 401643 401699 401718 401731 401761 401762 401784 401798 401815 401844 401869 401874 401886 401993 402003 402015 402032 402116 402119 402152 402210 402245 402263 402277 402295 402302 402389 402393 402394 402414 402432 402433 402459 400321 400549 401077 402088 402342 402410 400043 400125 400199 400200 400702 401329 401434 401658 401661 401726 401852 402059 402373 401455 401626 401720 401854 402272 402328 402340 402343 402347 402348 402349 402355 401253 401295 401435 401456 401465 401498 401673 402005 402076 400755 400808 400926 401217 401615 401619 401931 401937 401990 402309 402384 402388 402425 402491 400150 400426 400427 400428 400429 400495 400568 400624 400744 400756 400806 400850 400950 401119 401126 401192 401312 401389 401431 401447 401473 401490 401492 401563 401585 401605 401687 401773 401932 401933 401942 401944 401953 401954 401955 401960 401967 401974 401984 401989 402046 402085 402133 402212 402232 402267 402291 402308 402321 402378 402405 402409 400115 400155 400157 400180 400207 400307 400416 400418 400422 400424 400500 400551 400566 400599 400600 400601 400608 400696 400704 400711 400727 400801 400834 400911 400927 400933 400977 401068 401079 401122 401179 401199 401214 401215 401218 401219 401224 401227 401238 401240 401242 401270 401276 401293 401313 401317 401330 401349 401362 401382 401395 401408 401428 401451 401459 401521 401541 401582 401594 401595 401624 401632 401637 401640 401666 401688 401689 401695 401712 401755 401759 401786 401824 401853 401897 401901 401912 401983 402016 402034 402112 402117 402198 402199 402201 402213 402225 402288 402293 402311 402335 402381 402461 402482 402506 402507 402536 402569 402575 402209 400421 400185 400827 400488 402486 401396 400205 400569 400880 401820 401895 401978 402141 402203 401251 401812 400523 400524 400614 400745 400778 400802 401004 401074 401203 401504 401508 401519 401546 401622 401808 401875 402019 402106 402138 402159 402270 402464 400240 400591 400901 401332 401785 402221 402331 402408 402416 402430 402437 402465 401627 401324 401818 402434 400247 400263 400276 400281 400511 400514 400703 401887 402080 402435 400113 400237 400241 400256 400286 400323 400327 400328 400329 400330 400332 400333 400335 400413 400419 400432 400434 400482 400525 400598 400602 400607 400609 400625 400627 400644 400648 400651 400653 400677 400684 400706 400714 400780 400785 400819 400824 400825 400826 400838 400842 400844 400845 400859 400863 400869 400871 400906 400910 400916 400937 400938 400971 400976 401032 401051 401053 401057 401058 401059 401060 401062 401076 401091 401092 401093 401094 401095 401097 401162 401164 401166 401167 401168 401170 401171 401172 401201 401202 401205 401206 401212 401221 401222 401262 401263 401264 401296 401297 401298 401299 401310 401339 401340 401341 401352 401353 401354 401357 401414 401415 401416 401417 401418 401419 401420 401421 401468 401479 401480 401481 401482 401483 401484 401485 401486 401488 401530 401531 401534 401535 401670 401671 401672 401675 401677 401679 401682 401684 401701 401702 401703 401714 401715 401716 401717 401739 401742 401777 401778 401779 401788 401789 401790 401792 401829 401834 401871 401894 401904 401909 401920 401925 401928 401930 401934 401935 401936 401939 401952 401956 401966 401968 401971 401972 401973 401975 401976 401980 401988 402000 402004 402043 402044 402045 402052 402100 402103 402104 402108 402110 402123 402132 402153 402164 402166 402169 402170 402171 402356 402358 402362 402364 402367 402368 401816 400594 400724 400846 400973 401045 401318 401411 401749 401884 401891 401893 402053 402494 400490 400497 400219 400966 400995 401039 401186 401254 401593 401664 401781 402033 402224 402247 402540 400087 400158 400159 400160 400161 400170 400172 400181 400182 400184 400187 400191 400192 400211 400248 400249 400250 400279 400284 400298 400301 400339 400494 400512 400531 400537 400539 400544 400579 400588 400590 400596 400605 400632 400639 400688 400719 400721 400738 400739 400741 400761 400798 400805 400812 401026 401129 401145 401146 401153 401157 401183 401195 401200 401207 401220 401331 401356 401374 401381 401398 401399 401646 401767 401768 401770 401858 402060 402070 402098 402297 402550 400252 401082 401085 401566 402419 400561 400705 400718 400747 400750 400751 400754 400837 400841 401087 401178 401439 401502 401814 402111 400255 400417 400542 400559 400571 400574 400576 400655 400748 400839 400870 400879 400917 401147 401151 401152 401211 401228 401230 401233 401259 401301 401668 401690 402204 402246 402265 402276 402300 402504 402558 402582 401148 401231 400101 400578 401905 402122 402402 402521 400585 400690 401019 401024 401321 401401 401745 402380 402428 400173 400278 400345 400406 400423 400521 400553 400563 400606 400645 400692 400701 400725 400769 400943 400984 401277 401442 401454 401999 402218 402274 400165 400178 400214 400262 400266 400271 400274 400275 400414 400420 400430 400565 400616 400760 400823 400876 400915 400922 400928 400934 401113 401131 401150 401272 401274 401292 401302 401303 401304 401367 401394 401464 401466 401617 401630 401634 401651 401652 401657 401659 401663 401665 401676 401681 401685 401686 401694 401698 401709 401721 401723 401775 401819 401823 401835 401888 401998 402062 402063 402065 402071 402074 402079 402091 402092 402140 402172 402173 402189 402195 402269 402385 402424 402539 400253 400403 400498 400581 400728 400765 402231 402241 400189 400897 400924 400969 401042 401154 401161 402372 402383 402401 402422 402440 402488 402024 400584 400587 400908 401970 400646 400796 400836 400840 401084 401086 401306 402001 402363 400127 400300 400401 400469 400603 400619 400637 400642 400946 400948 400957 400963 401000 401017 401046 401118 401185 401764 401780 402069 402445 401609 402040 400218 400277 400342 400476 400990 401127 401180 401197 402073 402292 402350 400856 401817, and  402441.

Radiology Devices

2

No

Worldwide Distribution -- US and Albania, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mexico, Netherlands, New Zealand, Nigeria, Norway, P.R. China, Pakistan, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

ACUSON SC2000 ultrasound systems || model 10433816 || Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.