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Panels › Radiology › Product code IZI · Class 2

System, X-Ray, Angiographic

Regulation 892.1600

2510(k)s in 12 months (199 all time)
1recalls in 12 months (259 all time)
240recalls that name a 510(k)
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Top companies in IZI

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.1398
Philips Medical Systems North America Co. Phillips055
Philips Electronics North America Corporation034
GE Healthcare226
GE Medical Systems103
Shimadzu Medical Systems85
Novadaq Technologies, Inc.93
Philips Medical Systems64
Xre Corp.100
Philips Medical Systems North America Co.90
Decided510(k)Device and applicantCode
Aug 28, 1991K912416ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM
Xre Corp.
IZI
Aug 16, 1991K913120POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM
Siemens Medical Solutions USA, Inc.
IZI
Jun 21, 1991K905518BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
Venusa , Ltd.
IZI
Jun 6, 1991K910654CINEMEASURE (TM)
Syracuse Research Corp.
IZI
May 28, 1991K910370PHILIPS INTEGRIS V3000 AND V4000
Philips Medical Systems, Inc., NL
IZI
May 15, 1991K905653ADVANTX AFM ANGIO SYSTEM S1808
GE Medical Systems
IZI
Mar 26, 1991K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEM
North American Instrument Corp.
IZI
Feb 4, 1991K903941SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400
Shimadzu Medical Systems
IZI
Nov 29, 1990K903373CATHETERIZATION C-ARM SUPPORT MH-51C(F)
Shimadzu Medical Systems
IZI
Nov 29, 1990K903372CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A
Shimadzu Medical Systems
IZI
Nov 29, 1990K903371CATHETERIZATION C-ARM SUPPORT MH-51B(F)
Shimadzu Medical Systems
IZI
Oct 26, 1990K904540VIDEO SYSTEM INTERFACE MODELS
Perkins Mfg. Co.
IZI
Oct 17, 1990K904447SONY CINE VIDEO SYSTEM SME-3500
Sony Medical Electronics Co.
IZI
Oct 1, 1990K903375HICOR
Siemens Gammasonics, Inc.
IZI
Aug 17, 1990K902542PHILIPS INTEGRIS C2000 SYSTEM
Philips Medical Systems North America, Inc.
IZI
Mar 13, 1990K897115ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
Toshiba America Medical Systems, In.C
IZI
Nov 17, 1989K896088FEMORAL ANGIOGRAPHY DRAPE
Medical Plastics, Inc.
IZI
Aug 9, 1989K892849UNICATH A
Xre Corp.
IZI
Feb 27, 1989K890348LC, CARDIAC POSITIONER #B5078A
General Electric Co.
IZI
Feb 22, 1989K890352MULTISKOP
Siemens Medical Solutions USA, Inc.
IZI
Feb 16, 1989K884912ANGIOSTAR
Siemens Medical Solutions USA, Inc.
IZI
Nov 30, 1988K884008SONY CINE VIDEO SYSTEM SME-3300
Sony Medical Electronics Co.
IZI
Nov 21, 1988K883860ADVANTAGE
Fischer Imaging Corp.
IZI
Nov 21, 1988K883831IMAGER
Fischer Imaging Corp.
IZI
Oct 31, 1988K880690SIEMENS PACS/I-A
Siemens Gammasonics, Inc.
IZI
Oct 19, 1988K882358PULSED FLUOROSCOPIC CONTROL MODEL:PF-02
U.S. Imaging, Inc.
IZI
Sep 14, 1988K883072DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM
Siemens Gammasonics, Inc.
IZI
Jul 1, 1988K874910SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200
Shimadzu Precision Instruments, Inc.
IZI
Feb 12, 1988K875380SHIMADZU CATHETERIZATION C-ARM STAND MH-10
Shimadzu Precision Instruments, Inc.
IZI
Feb 12, 1988K875379SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A
Shimadzu Precision Instruments, Inc.
IZI
Feb 12, 1988K875376SHIMADZU CATHETERIZATION C-ARM STAND MH-50B
Shimadzu Precision Instruments, Inc.
IZI
Feb 12, 1988K875375SHIMADZU LATERAL C-ARM MH-30
Shimadzu Precision Instruments, Inc.
IZI
Feb 12, 1988K875374SHIMADZU CEILING-SUSPENDED C-ARM CH-50
Shimadzu Precision Instruments, Inc.
IZI
Feb 12, 1988K875373C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20
Shimadzu Precision Instruments, Inc.
IZI
Feb 12, 1988K875372SHIMADZU CATHETERIZATION C-ARM STAND ER-200
Shimadzu Precision Instruments, Inc.
IZI
Jan 29, 1988K875184UNICATH LAB
Xre Corp.
IZI
Aug 1, 1986K852331SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC
Scholten Surgical Instruments, Inc.
IZI
Nov 1, 1985K853044STERICOVER
Sterimed, Inc.
IZI
May 6, 1985K850455QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM
Xre Corp.
IZI
Aug 17, 1984K842495MATRIX VIDEO IMAGER 1020 COMPACT CAMER
Matrix Instruments
IZI
Aug 17, 1984K842494MATRIS INSTRU. VIDEO IMAGER 1010-
Matrix Instruments
IZI
Feb 21, 1984K834496ISOREX LS-36
Elscint, Inc.
IZI
Feb 4, 1982K813588CTF MODEL 9300
Thomson-Csf Broadcast, Inc.
IZI
Nov 24, 1981K812913OMEGA II ANGIOGRAPHIC TABLE
General Electric Co.
IZI
Nov 4, 1981K812721DIGITRON
Siemens Corp.
IZI
Sep 11, 1981K812238D.I.V.A.S.
Cgr Medical Corp.
IZI
Jun 9, 1981K811149PANDOROS 1200A
Siemens Corp.
IZI
Feb 25, 1981K810183PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION
Philips Medical Systems (Cleveland), Inc.
IZI
Dec 7, 1978K781991ANGIOSKIP
Siemens Corp.
IZI

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