FDA Product Code
FDA Product Code IZI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1600
510(k) Clearances — 199 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K946378 | BCM 400CP | B C Medical , Ltd. | 1995-05-04 | Traditional | PDF ↗ |
| K945449 | UNICATH LLU ANGIOGRAPHIC SYSTEM | Xre Corp. | 1995-02-27 | Traditional | PDF ↗ |
| K944952 | ANGIOGRAPHIC SYSTEM | Acoma Medical Imaging, Inc. | 1995-02-17 | Traditional | PDF ↗ |
| K943545 | CEILING SUSPENDED C-ARM SUPPORT MH-100 | Shimadzu Medical Systems | 1995-02-03 | Traditional | PDF ↗ |
| K945375 | ADVANTX LCA | GE Medical Systems | 1995-01-30 | Traditional | PDF ↗ |
| K945459 | DLX | General Electric Co. | 1995-01-30 | Traditional | PDF ↗ |
| K945293 | TOP ACOM STATION | Siemens Medical Solutions USA, Inc. | 1995-01-05 | Traditional | PDF ↗ |
| K945483 | COMPAS | General Electric Co. | 1994-12-09 | Traditional | PDF ↗ |
| K943355 | GEMNET | GE Medical Systems | 1994-11-07 | Traditional | PDF ↗ |
| K940172 | CARDIOVASCULAR MEASUREMENT SYSTEM-CMS | Medis Medical Imaging Systems, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K936002 | CINEMAC QAS | Xre Corp. | 1994-09-09 | Traditional | PDF ↗ |
| K935026 | DIGITAL MEDIA CONVERTER (D-MC) | Eigen Video | 1994-08-24 | Traditional | PDF ↗ |
| K941979 | VIDEO PLUS WITH ANALYTICAL WORKSTATION | Camtronics, Ltd. | 1994-08-17 | Traditional | PDF ↗ |
| K942503 | UNICATH FAMILY | Angiographic Devices Corp. | 1994-07-20 | Traditional | PDF ↗ |
| K942120 | ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION | GE Medical Systems | 1994-07-18 | Traditional | PDF ↗ |
| K941177 | ANGIOREX CAS-05A | Toshiba America Medical Systems, In.C | 1994-06-06 | Traditional | PDF ↗ |
| K941946 | LCA ANGIOGRAPHIC IMAGING SYSTEM | GE Medical Systems | 1994-05-20 | Traditional | PDF ↗ |
| K940484 | COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K933460 | DVFX, MODEL M256 | Xre Corp. | 1994-04-07 | Traditional | PDF ↗ |
| K933664 | POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) | Siemens Gammasonics, Inc. | 1993-12-15 | Traditional | PDF ↗ |
| K932410 | HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY | Heartware Intl. Corp. | 1993-12-13 | Traditional | PDF ↗ |
| K934496 | X-RAY ANGIOGRAPHIC SYSTEM | Camtronics, Ltd. | 1993-12-13 | Traditional | PDF ↗ |
| K931184 | MULTI-VIEW PROCESSOR (MVP) | Adac Laboratories | 1993-11-02 | Traditional | PDF ↗ |
| K933073 | HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE | Heartware Intl. Corp. | 1993-10-07 | Traditional | PDF ↗ |
| K933058 | HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW | Heartware Intl. Corp. | 1993-09-28 | Traditional | PDF ↗ |
| K930635 | MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K931170 | SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) | Sony Medical Systems | 1993-06-14 | Traditional | PDF ↗ |
| K926258 | DLX | GE Medical Systems | 1993-03-15 | Traditional | PDF ↗ |
| K925961 | OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM | Diagnostic Archives, Inc. | 1993-03-02 | Traditional | PDF ↗ |
| K924708 | CINENET CARDIAC IMAGE NETWORK | Sony Medical Systems | 1992-12-30 | Traditional | PDF ↗ |
| K924719 | ANCOR | Siemens Medical Solutions USA, Inc. | 1992-12-30 | Traditional | PDF ↗ |
| K926082 | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT | Biodan Medical Systems, Ltd. | 1992-12-30 | Traditional | PDF ↗ |
| K924137 | CSP-A (CEILING SUSPENDED POSITIONER-ANGIO) | Fischer Imaging Corp. | 1992-12-28 | Traditional | PDF ↗ |
| K924828 | BI-N | Xre Corp. | 1992-12-17 | Traditional | PDF ↗ |
| K922222 | ANGIOGRAPHIC X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 1992-12-02 | Traditional | PDF ↗ |
| K923654 | POLY DIAGNOST CDX | Xre Corp. | 1992-11-20 | Traditional | PDF ↗ |
| K923813 | PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION | Philips Medical Systems, Inc. | 1992-10-16 | Traditional | PDF ↗ |
| K920862 | BCM-400C | B C Medical , Ltd. | 1992-09-30 | Traditional | PDF ↗ |
| K923112 | ANGIO-BAND | Cook, Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K922804 | AWOS ANGIOGRAPHIC WORKSTATION | Siemens Medical Solutions USA, Inc. | 1992-08-28 | Traditional | PDF ↗ |
| K922622 | PHILIPS CARDIAC WORKSTATION | Philips Medical Systems, Inc. | 1992-08-11 | Traditional | PDF ↗ |
| K921101 | PHILIPS INTEGRIS V3000 FILM | Philips Medical Systems, Inc. | 1992-05-15 | Traditional | PDF ↗ |
| K920705 | POLYTRON DIGITAL IMAGING SYSTEM | Siemens Medical Solutions USA, Inc. | 1992-04-27 | Traditional | PDF ↗ |
| K920434 | ATLAS 2000 VASCULAR ROAD MAPPING SYSTEM | Squires & Assoc., Inc. | 1992-04-13 | Traditional | PDF ↗ |
| K914376 | DXS DIGITAL X-RAY SUBTRACTION | Philips Medical Systems (Cleveland), Inc. | 1992-02-04 | Traditional | PDF ↗ |
| K915199 | STORZ IMAGING SYSTEM | Fischer Imaging Corp. | 1992-01-23 | Traditional | PDF ↗ |
| K915232 | GRUNDIG ELECTRONICS VARIOUS MODELS | Perkins Mfg. Co. | 1992-01-09 | Traditional | PDF ↗ |
| K914313 | HICOR | Siemens Gammasonics, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K913685 | UNICATH EP. | Xre Corp. | 1991-11-07 | Traditional | PDF ↗ |
| K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE | Advance Medical Designs, Inc. | 1991-09-16 | Traditional | PDF ↗ |
| K912416 | ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM | Xre Corp. | 1991-08-28 | Traditional | PDF ↗ |
| K913120 | POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K905518 | BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET | Venusa , Ltd. | 1991-06-21 | Traditional | PDF ↗ |
| K910654 | CINEMEASURE (TM) | Syracuse Research Corp. | 1991-06-06 | Traditional | PDF ↗ |
| K910370 | PHILIPS INTEGRIS V3000 AND V4000 | Philips Medical Systems, Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K905653 | ADVANTX AFM ANGIO SYSTEM S1808 | GE Medical Systems | 1991-05-15 | Traditional | PDF ↗ |
| K903493 | NAMIC CONTRAST SAVINGS DELIVERY SYSTEM | North American Instrument Corp. | 1991-03-26 | Traditional | PDF ↗ |
| K903941 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 | Shimadzu Medical Systems | 1991-02-04 | Traditional | PDF ↗ |
| K903371 | CATHETERIZATION C-ARM SUPPORT MH-51B(F) | Shimadzu Medical Systems | 1990-11-29 | Traditional | PDF ↗ |
| K903372 | CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A | Shimadzu Medical Systems | 1990-11-29 | Traditional | PDF ↗ |
| K903373 | CATHETERIZATION C-ARM SUPPORT MH-51C(F) | Shimadzu Medical Systems | 1990-11-29 | Traditional | PDF ↗ |
| K904540 | VIDEO SYSTEM INTERFACE MODELS | Perkins Mfg. Co. | 1990-10-26 | Traditional | PDF ↗ |
| K904447 | SONY CINE VIDEO SYSTEM SME-3500 | Sony Medical Electronics Co. | 1990-10-17 | Traditional | PDF ↗ |
| K903375 | HICOR | Siemens Gammasonics, Inc. | 1990-10-01 | Traditional | PDF ↗ |
| K902542 | PHILIPS INTEGRIS C2000 SYSTEM | Philips Medical Systems North America, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K897115 | ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM) | Toshiba America Medical Systems, In.C | 1990-03-13 | Traditional | PDF ↗ |
| K896088 | FEMORAL ANGIOGRAPHY DRAPE | Medical Plastics, Inc. | 1989-11-17 | Traditional | PDF ↗ |
| K892849 | UNICATH A | Xre Corp. | 1989-08-09 | Traditional | PDF ↗ |
| K890348 | LC, CARDIAC POSITIONER #B5078A | General Electric Co. | 1989-02-27 | Traditional | PDF ↗ |
| K890352 | MULTISKOP | Siemens Medical Solutions USA, Inc. | 1989-02-22 | Traditional | PDF ↗ |
| K884912 | ANGIOSTAR | Siemens Medical Solutions USA, Inc. | 1989-02-16 | Traditional | PDF ↗ |
| K884008 | SONY CINE VIDEO SYSTEM SME-3300 | Sony Medical Electronics Co. | 1988-11-30 | Traditional | PDF ↗ |
| K883860 | ADVANTAGE | Fischer Imaging Corp. | 1988-11-21 | Traditional | PDF ↗ |
| K883831 | IMAGER | Fischer Imaging Corp. | 1988-11-21 | Traditional | PDF ↗ |
| K880690 | SIEMENS PACS/I-A | Siemens Gammasonics, Inc. | 1988-10-31 | Traditional | PDF ↗ |
| K882358 | PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 | U.S. Imaging, Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K883072 | DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM | Siemens Gammasonics, Inc. | 1988-09-14 | Traditional | PDF ↗ |
| K874910 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 | Shimadzu Precision Instruments, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K875376 | SHIMADZU CATHETERIZATION C-ARM STAND MH-50B | Shimadzu Precision Instruments, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K875374 | SHIMADZU CEILING-SUSPENDED C-ARM CH-50 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K875373 | C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K875375 | SHIMADZU LATERAL C-ARM MH-30 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K875379 | SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A | Shimadzu Precision Instruments, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K875372 | SHIMADZU CATHETERIZATION C-ARM STAND ER-200 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K875380 | SHIMADZU CATHETERIZATION C-ARM STAND MH-10 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K875184 | UNICATH LAB | Xre Corp. | 1988-01-29 | Traditional | PDF ↗ |
| K852331 | SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC | Scholten Surgical Instruments, Inc. | 1986-08-01 | Traditional | PDF ↗ |
| K853044 | STERICOVER | Sterimed, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K850455 | QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM | Xre Corp. | 1985-05-06 | Traditional | PDF ↗ |
| K842494 | MATRIS INSTRU. VIDEO IMAGER 1010- | Matrix Instruments | 1984-08-17 | Traditional | PDF ↗ |
| K842495 | MATRIX VIDEO IMAGER 1020 COMPACT CAMER | Matrix Instruments | 1984-08-17 | Traditional | PDF ↗ |
| K834496 | ISOREX LS-36 | Elscint, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K813588 | CTF MODEL 9300 | Thomson-Csf Broadcast, Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K812913 | OMEGA II ANGIOGRAPHIC TABLE | General Electric Co. | 1981-11-24 | Traditional | PDF ↗ |
| K812721 | DIGITRON | Siemens Corp. | 1981-11-04 | Traditional | PDF ↗ |
| K812238 | D.I.V.A.S. | Cgr Medical Corp. | 1981-09-11 | Traditional | PDF ↗ |
| K811149 | PANDOROS 1200A | Siemens Corp. | 1981-06-09 | Traditional | PDF ↗ |
| K810183 | PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION | Philips Medical Systems (Cleveland), Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K781991 | ANGIOSKIP | Siemens Corp. | 1978-12-07 | Traditional | PDF ↗ |
Product code IZI · Class II · Radiology. Data: openFDA.