Device Recall Digital Fluoroscopic Imaging System

  • 모델명 / 제조번호(시리얼번호)
    00000108/61094 1003100013 0000010031000L 00000452818BU8 00000704/20108 1103100019 1103100019 00000404/10070 104100053 104100051 104100057 00000452834BU5 1104120128 00000452889BU9 00000452890BU7 00000524134BU4 00001104/20167 909110081 1103100025 00000452863BU4 000005041A0050 0000904/201135 00000405/40184 00001104/20157 00000704/20105 00000452867BU5 00000604/10092 00000452856BU8 1103100021 00000569/100S1 204110065 00000452886BU5 00000607/60971 00000469421BU2 106100066 1003100009 00000453141BU4 00001204/30186 00001104/20172 00000466711BU9 00000704/20102 00000469228BU1 1103100017 00000707/50172 30177 100300002 110300023 1103100026 00001003/00002 00001103/00023 00000452894BU9 609110902 00000304/20129 00000404/10078 00000704/20112 00000105/30149 00000466679BU8 104100050 00000707/60998 00000469313BU1 00000307/50908 00000807/61002 00000805/40289 00000452817BU0 00001207/61076 00000105/30150 00000469278BU6 00001004/20007 00001207/60203 00000469262BU0 00001207/61070 00000524144BU3 00000807/61012 00000469252BU1 00000707/50611 00000524120BU3 00000807/61005 00000805/40263 00001107/60651 00000405/40252 00001003/00006 00000453164BU6 00001204/30189 204110049 00000536915BU2 00000452844BU4 00001204/30200 00000507826BU6 00000536925BU1 00000460519BU2 00000466701BU0 00000452849BU3 1203100025 00000104/00052 00000452839BU4 00000536863BU4 00000460617BU4 00000452815BU4 00000452838BU6 1203100041 304110072 24110061 204110061 00000466746BU5 00001003/00012 00001203/00035 00000453138BU0 110360007 00000104-00014 00001004/20150 00000604/20095 00000604/20098 00000704/20111 00000453136BU4 00000453179BU4 00000452868BU3 00000452797BU4 00000461248BU7 00001204/30197 00000104/00044 00001204/30147 00000460593BU7 1203100038 00000466744BU0 00000452810BU5 704120118 00000452819BU6 00000507/50936 00000604/10087 00000112450VE2 00000460543BU2 00001003/00008 00000452816BU2 00000499172BU5 and 00000499169BU1
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • 제품 설명
    Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment..
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 10 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    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000407/50588 00000469270BU3 00000507/50945 and 00000507/50946
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • 제품 설명
    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    00000466713BU5 00000466705BU1 00000524119BU5 00000536916BU0 00000112428VE8 00000460509BU3 00000507823BU3 00000460516BU8 00000469271BU1 00000460505BU1 00000460528BU3 00000466687BU1 00000536866BU7 00000405/40253 00000466707BU7 00000307/50880 00000520248BU6 00000460549BU9 00000307/50896 00000469345BU3 00000112416VE3 00000466740BU8 00000460554BU9 00000469342BU0 00000466739BU0 00000466743BU2 00000466677BU2 00000460504BU4 00000466762BU2 00000307/50866 00000460623BU2 00000407/50914 00000536903BU8 00000707/60983 00000507796BU1 00000524158BU3 00000469363BU6 00000520259BU3 00000536827BU9 00000707/60999 00000466754BU9 00000493790BU0 00000520267BU6 00000112421VE3 00000493801BU5 00000407/50170 00000469344BU6 00000452845BU1 00000112418VE9 00000469335BU4 00000112431VE2 00000807/61017 00000469351BU1 00000460631BU5 00000469312BU3 00000452829BU5 00000520264BU3 00000536837BU8 00000605/00051 00000460609BU1 00000520276BU7 00000112419VE7 00000469370BU1 00000469358BU6 00000493805BU6 00000524117BU9 00000460520BU0 00000466675BU6 00000460511BU9 00000483699BU5 00000536839BU4 00000460615BU8 00000469328BU9 00000207-50843 00000466751BU5 00000469263BU8 00000507/50938 00000524147BU6 00000452812BU1 00000460569BU7 00000452921BU0 00000453224BU8 00000466767BU1 00000460503BU6 00000206/40463 00000524124BU5 00000460597BU8 00000407/50916 40372 00000452901BU2 404110077 00000466684BU8 00000536876BU6 00000536850BU1 00000536913BU7 00000466756BU4 00000469269BU5 00000507813BU4 00000112405VE6 00000112410VE6 00000460576BU2 00000466685BU5 00000466714BU3 00000466671BU5 00000536836BU0 00000108/60209 00000108/61090 00000707/60992 00000452836BU0 00001207/61063 00000907/60631 00000460585BU3 00000460563BU0 00000536904BU6 00000536922BU8 00000469372BU7 00000112447VE8 00000207/50856 00000460562BU2 00000520294BU0 00000707/60614 00000466674BU9 00000452840BU2 00000466734BU1 00000469299BU2 00000452826BU1 00000466700BU2 00000460532BU5 00000452841BU0 00000112452VE8 00000469302BU4 00000469244BU8 00000453158BU8 00000466735BU8 00000469224BU0 00000469282BU8 00000112400VE7 00000607/50602 00000469297BU6 00000466717BU6 00000524113BU8 00000507/50957 00000452927BU7 00000112436VE1 00001007/61039 00001007/61038 00000493808BU0 00000460510BU1 00000469272BU9 00000466681BU4 00000469288BU5 00000807/50176 00000520293BU2 00000469289BU3 00000469294BU3 00000469256BU2 00000469275BU2 00000460589BU5 00000536838BU6 00000460538BU2 00000466752BU3 00000307/50881 00000520274BU2 00000507/50950 00000520257BU7 00000524135BU1 00000507781BU3 00000507775BU5 00000536865BU9 00000707/50970 00000524161BU7 00000507797BU9 00000507784BU7 00000469401BU4 00000450567BU1 00000524143BU5 00001107/61052 00000469245BU5 00000806/00082 00000907/00156 00000460540BU8 00000460531BU7 00000460605BU9 00000112449VE4 00000607/50967 00000466730BU9 00000460526BU7 00000507/50922 00000469375BU0 00000460542BU4 00000469325BU5 00000499146BU9 00000499147BU7 00000520292BU4 00000469238BU0 00000460553BU1 00000469257BU0 00000520298BU1 00001107/61050 00000469259BU6 00000520258BU5 00000466747BU3 00000493803BU1 00000536891BU5 00000907/60637 00001107/60657 00000469399BU0 00000407/50586 00000407/50590 00000407/50596 00000469276BU0 00000507837BU3 00000469248BU9 00000507830BU8 00001207/60664 00000507838BU1 00000407/50165 00000520270BU0 00000469261BU2 00000507788BU8 00000707/50610 00000536923BU6 00000466742BU4 00000536854BU3 00000469290BU1 00000524150BU0 00000469281BU0 00000469258BU8 00000499178BU2 00000507772BU2 00000483696BU1 00000452934BU3 00000493794BU2 00000499180BU8 00000536832BU9 00000452914BU5 00000452908BU7 00000407/50164 00000483691BU2 00000452900BU4 00000807/60183 00000112456VE9 00000469333BU9 00000469387BU5 00000499154BU3 00000707/60980 00000469307BU3 00000466697BU0 00000469233BU1 00000524133BU6 00000112446VE0 00000707/50609 00000466731BU7 00000466718BU4 00000307/50882 00000460620BU8 00000469396BU6 00000524172BU4 00000469386BU7 00000524171BU6 00000507836BU5 00000707/60984 00000707/60617 00000469324BU8 00000707/50976 00000452831BU1 00000520240BU3 00000307/50889 00000469284BU4 00000520253BU6 00000607/50604 00000507839BU9 00000507/50952 00000469360BU2 and 00000307/50909
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • 제품 설명
    GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    00000469348BU7 00000536877BU4 404110063 00000452883BU2 00000504/10096 00000460596BU0 00000469365BU1 00000704/20115 704120114 00000536912BU9 00000460572BU1 00000052416BU0 00000460630BU7 00000307/50895 120310008 00001104/20158 00000507/50928 00000460594BU5 00000452882BU4 00000453177BU8 00000461253BU7 00000307/50879 20116 00001004/20116 00000307/50884 1003100012 00000536843BU6 00000469338BU8 00000112413VE0 50410084 00000452854BU3 00000453150BU5 00000453167BU9 00000524168BU2 904120023 00000452892BU3 00000112412VE2 00000524121BU1 00000469322BU2 00000112461VE9 00000507/50921 00000507767BU2 00000469371BU9 00000112408VE0 00000905/40399 00000453140BU6 00000907/61022 00001003/00003 00000469364BU4 1203100039 00000452885BU7 00000469346BU1 404110064 00000452862BU6 00000507812BU6 00000499183BU2 00000499131BU1 00000483701BU9 00000452873BU3 1203100032 00000466706BU9 0000066706BU94 00000452871BU7 00000536900BU4 00000112403EV1 00000112403VE1 1203100034 1003 00000453165BU3 00000469337BU0 404110079 00000469264BU6 00000466763BU0 00000520277BU5 110310015 00000469330BU5 00000524129BU4 00001004/20145 00000404/10086 104100047 304110017 00000GD60U6-GE 00000904/20130 00000453213BU1 00000469394BU1 1103100020 00000461251BU1 1203100033 110420162 00000469367BU7 00000466688BU9 00000469381BU8 00000469350BU3 00000460560BU6 504110085 00000112397VE5 00000307/50868 00000507832BU4 00000307/50877 00000452828BU7 00000524154BU2 00000GD60U4-GE 00000469407BU1 904 00000524163BU3 00000460611BU7 00000466709BU3 00000460579BU6 00000104/00046 00000461252BU9 00000460568BU9 0000CA04110576 00000112434VE6 00000466755BU6 00000704/20106 00000520281BU7 00000499151BU9 00000469227BU3 00000469240BU6 00000460591BU1 00000104/00042 1204130176 00000499150BU1 00000507805BU0 00000452848BU5 604120099 00000307/50886 00000105/30203 00000105/32203 00000452880BU8 00000907/60635 1204130198 00000307/50885 00000469310BU7 00000804/20123 00001003/00007 1003100004 00000507815BU9 00000493792BU6 00000105/30201 00000460570BU5 00000507/50937 00000707/60995 00000461250BU3 00000524155BU9 00000507771BU4 00000524137BU7 00000452861BU8 00000507818BU3 00000104/00048 00000404/10074 00001204/30196 00000112398VE3 00000520251BU0 00000520278BU3 00001207/61080 00000507766BU4 00000805/40266 00000469317BU2 00000404/16671 00001207/61071 00000108/61116 00001207/60662 00001207/61067 00001104/20129 00000807/61014 00000108/61106 00000524114BU6 00000452811BU3 00001207/61087 00001007/61035 00001207/61064 00000460601BU8 00001207/60196 00001207/61081 00000453211BU5 00000469273BU7 00000108/61099 00000460577BU0 00000466745BU7 00000404/10066 00000707/60981 00000452879BU0 00000707/61001 00000453170BU3 00001004/20119 00001007/61034 00000108/61095 00000707/60988 00000707/61000 00001004/20146 00000460618BU2 00001207/60200 00000536872BU5 00000507/50931 00000507/50932 00000520299BU9 00001206/30188 00000507793BU8 00001104/20170 00000307/50888 00000536917BU8 00000524164BU1 00000452800BU6 00000507827BU4 00000469305BU7 00000520242BU9 00000507/50951 304110070 00000536832BU1 00000469393BU3 00001203/00034 00000112438VE7 00001203/00030 00000460566BU3 00000604/20097 00000469379BU2 00000507/50954 00000807/60622 00000807/61006 00000453135BU6 00000507/50953 00000407/50587 00000469391BU7 00000460575BU4 00000707/50975 00001104/20134 00000499165BU9 00000469241BU4 00000469253BU9 00000466761BU4 00000499189BU9 00000469331BU3 1204130137 00000499142BU8 00000108/60208 00000112454VE4 00000493796BU3 00000112401VE5 00000407/50918 00000469339BU6 00000507824BU1 00000452803BU0 00000507/50930 00000208/61132 00000404/10074 00000466703BU6 00000524130BU2 00000524160BU9 00001107/61060 00000507799BU5 and 00000807/60623
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • 제품 설명
    GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    00001104/20163 00000453208BU1 00000604/20009 00000452923BU6 00001104/20026 1003000011 106100046 304110016 00000483694BU6 1103100017 00000483695BU3 00001004/20125 00000452904BU6 00000905/40049 50410007 00000904/20132 00000904/20010 00001103/20127 00000404/10003 00000466738BU2 1203100011 00000453217BU2 00001103/00006 00000045295BU1 1203100009 120340010 00000461244BU6 00000499182BU4 00000453148BU9 00000460515BU0 00000461241BU2 00001204/30194 00000453153BU9 00000705/40244 00000452906B01 00000452906BU1 00000453194BU3 00000453146BU3 00000604/20019 00000466737BU4 00001107/61054 00000453132BU3 00000453154BU7 00000453156BU2 00000453161BU2 00000469231BU5 00000452821BU2 00000461245BU3 00000112406VE4 00000461242BU0 00000453152BU1 00000461246BU1 00000461247BU9 00000461243BU8 00001107/00019 00000469389BU1 00000452835BU2 00000466670BU7 00000469265BU3 00000466721BU8 00000453149BU7 and 00000453216BU4
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • 제품 설명
    Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    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and 00000536847BU7
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • 제품 설명
    Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment.
  • Manufacturer
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