Syngo.via

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 220755 101060 220807 221363 220497 221053 100662 130301 101494 130643 101312 310364 102213 221225 130653 220687 220811 310395 102048 100741 102523 101739 221244 102125 102401 310397 102036 220939 100915 221110 100598 130765 130321 130118 310310 102477 130692 102008 130159 101757 101773 100751 100713 101802 102535 310536 221199 102089 220451 101559 101479 130252 100417 100421 100641 100642 100644 100646 100418 100419 100420 100643 100645 100811 100812 100813 100814 102369 101521 221129 310363 220909 400047 100669 130326 101839 311011 130712 131011 101027 100744 130784 310524 311001 101313 101233 101114 221192 130201 130180 220604 100518 100735 102296 130629 102532 102158 101843 102447 102533 220930 102515 220684 220725 130908 102271 130309 102265 101638 102449 102377 102553 130396 101864 101826 102563 102374 100704 102340 310365 310388 102197 101938 100929 310348 100963 100729 221280 102229 102537 130852 100008 101355 101163 101192 102409 130539 101201 102490 101051 101205 101220 101202 101206 101854 220448 220466 400058 400061 130438 101046 101565 101612 102381 101855 101784 310486 101561 102113 221299 102064 101225 101515 221154 130628 130174 130175 130777 130635 102526 101834 102418 101183 102120 130377 101137 101740 220577 100485 221344 130569 221264 102455 130125 101701 100950 130267 101885 130716 101578 221345 310472 102108 100692 100826 102175 101371 100675 100700 101257 130229 220617 102142 130734 310396 102021 100760 101338 101354 130491 101566 130410 310460 101878 310410 130241 130242 130243 130244 102281 101251 101309 101631 130630 102031 100796 130563 102270 102405 220512 130916 130611 100620 101444 100957 310379 100039 130335 101998 130695 102417 221233 101043 101066 311012 101503 400062 100677 400065 221204 102127 101416 130837 100012 101267 130745 220855 102420 221390 102146 102511 220742 130149 102486 130376 101797 220288 101754 100633 101602 221319 102363 130266 102499 220454 102013 102291 102297 102298 101722 101723 101953 221296 221257 101520 100753 220876 130561 130140 221109 130631 221254 100734 101345 102560 101316 102576 130803 400042 220465 100411 101367 101958 100484 100583 101020 101182 100590 130711 220900 130386 101038 130327 101057 102444 220964 102097 100978 102470 100763 130751 130449 130761 130173 102475 131012 101010 130443 102209 310385 101650 130247 100771 100742 310418 130697 220163 102360
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Nationwide
  • 제품 설명
    Syngo.via picture archiving and communication system || Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 13 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model Number of device: 10496180, with serial numbers:  220755 101060 100509 220783 100662 220844 130208 102213 100862 101739 102125 102401 102402 130118 102024 102509 102477 102008 100751 101802 102089 101559 102407 130252 220915 220909 130267 101118 101313 101114 130180 100735 100495 102295 102532 220684 220725 102265 101638 102377 101432 102158 101864 130161 102374 102025 220511 102340 102197 101938 101647 100929 220206 100729 101201 101051 101220 101202 101206 101854 220448 220466 101565 100530 101612 102381 101561 220879 130174 102100 102418 100220 102120 220593 101137 101740 220577 102336 130125 101701 102335 101419 100748 101885 101578 101341 100460 102108 102175 100692 130122 101371 130378 100675 100700 101257 130229 220617 102021 100760 101338 102281 100718 101309 220888 101631 220920 100796 102405 220512 102435 100075 101444 100957 100039 102417 101043 101042 101066 220521 102127 101546 100705 220855 102420 102146 220742 102486 101797 101754 100633 102363 220743 130266 220454 100603 102074 101953 102173 102063 100892 100753 102163 220876 130140 130269 100734 101316 100845 101958 101200 101852 100484 220900 101038 101057 102355 100978 102014 130173 100917 101266 100389 101010 101650 100742 102360
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    310289,130542,130322,310149,130325,221063,310168,101762,221048,221096,220783,310195,130451,400031,130292,310114,220846,130269,130163,130402,130826,221051,102336,310282,220888,10007,221052,221049,130518,221002,221091,220915,130520,130472,100469,310249,130122,100013,130378,310188,102453,310079,310080,130240,130382,220985,310171,220879,220995, and 310268.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- AR, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TX, and UT.
  • 제품 설명
    Syngo.via, picture archiving and communications system software controlled. || Intended to be used for viewing, manipulation, communication, and storage of medical images.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Device Model Numbers: 10863171, 10863172, 10863173  Serial Numbers: 401018 221363 221402 310364 222027 221225 130653 310395 310397 221110 130765 310310 450002 130848 130849 130692 310536 131037 221199 131200 130773 401005 130874 130706 401004 310363 400047 131011 130784 401062 310361 221192 221373 401070 222060 310544 310365 310388 310348 221280 401024 130772 310486 130628 130777 130998 131160 222025 221403 221388 221344 131127 222023 130716 221345 310472 130808 221198 130734 310396 102021 310460 131192 131132 310410 221235 130563 130916 130611 401026 221411 130770 310379 130984 221233 222008 400065 221204 131165 130837 130754 131057 130816 221390 221319 221296 131006 221109 130631 401007 221254 131131 130889 130803 400042 130711 130751 221425 130761 131012 100771 310418 130697 131013
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Syngo.via, Picture archiving and communication system || Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Management ...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Syngo.via systems with VB20A. Model number 10496180.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Medical device software which needs to be installed.
  • 제품 설명
    Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Number 10496180
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Device is software only. No products are distributed to wholesale dealers, distributers or retailers
  • 제품 설명
    Syngo.via. Medical Device Software. Picture archiving and communications system.
  • Manufacturer
하나 더 8 건 더