FDA Product Code
FDA Product Code JAA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1650
510(k) Clearances — 300 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K963888 | C-ARM TABLE IVS-100 | Shimadzu Medical Systems | 1996-12-18 | Traditional | PDF ↗ |
| K963617 | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120 | Shimadzu Medical Systems | 1996-11-08 | Traditional | PDF ↗ |
| K961140 | FLUOROPLUS CARDIAC TV | Cmt Medical Technologies, Ltd. | 1996-09-20 | Traditional | PDF ↗ |
| K953974 | CAMVISION 1000 | Medivision Medical Imaging, Ltd. | 1996-09-09 | Traditional | PDF ↗ |
| K961207 | EP-X BIPLANE | Fischer Imaging Corp. | 1996-08-20 | Traditional | PDF ↗ |
| K962606 | TOPOGRAPHIC IMAGING MARKER | I.Z.I. Medical Products Corp. | 1996-08-07 | Traditional | PDF ↗ |
| K962140 | ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300 | Continental X-Ray Corp. | 1996-07-25 | Traditional | PDF ↗ |
| K961690 | CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 | Continental X-Ray Corp. | 1996-06-27 | Traditional | PDF ↗ |
| K961193 | FULL FRAME ZOOM SYSTEM | Xre Corp. | 1996-06-17 | Traditional | PDF ↗ |
| K955687 | RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | Contour Fabricators of Florida, Inc. | 1996-06-03 | Traditional | PDF ↗ |
| K953113 | SBDX MOBILE FLUOROSCOPY SYSTEM | Cardiac Mariners, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K951261 | DFI-1000 AND DVS-475 IMAGING DEVICES | Nical | 1996-03-15 | Traditional | PDF ↗ |
| K960266 | SIREGRAPH CF | Siemens Medical Solutions USA, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K954945 | HANEL MAVIG MONITOR SUSPENSION SYSTEM | F. Walter Hanel GmbH | 1996-01-29 | Traditional | PDF ↗ |
| K954590 | MAX-1000A/R1 | Toshiba America Medical Systems, In.C | 1995-11-20 | Traditional | PDF ↗ |
| K953950 | FLUORO CATHETER | Cmt Medical Technologies, Ltd. | 1995-09-18 | Traditional | PDF ↗ |
| K952493 | FLUORECORD MODEL 762 | Syracuse Scientific, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K952456 | IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM | Fisher Imaging Corp. | 1995-06-16 | Traditional | PDF ↗ |
| K950781 | COMPACT 7600 | Ge Dec Medical Systems | 1995-06-05 | Traditional | PDF ↗ |
| K946081 | FLUOREX DTA-400A | Toshiba America Medical Systems, In.C | 1995-05-24 | Traditional | PDF ↗ |
| K951358 | SIRESKOP SX | Siemens Medical Solutions USA, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K936236 | SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES | Shimadzu Medical Systems | 1995-05-11 | Traditional | PDF ↗ |
| K950683 | ARTHROGRAM TRAY | Surgical Technologies, Inc. | 1995-05-06 | Traditional | PDF ↗ |
| K943156 | SYSTEM, IMAGE PROCESSING | Image Technology, Inc. | 1995-05-04 | Traditional | PDF ↗ |
| K950971 | MOBIL C-ARM, REGURBISHED, VARIOUS MODELS | Pro-Tronics, Inc. | 1995-04-11 | Traditional | PDF ↗ |
| K950631 | ID400 SERIES ARMBOARDS | Image Diagnostics, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K945460 | PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION | Philips Medical Systems North America, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K941917 | FLUOROPLUA CARDIAC AND/OR INSTAVIEW | Fidelity Medical, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K942019 | MODEL FP-100 | International Medical Designs, Inc. | 1995-02-01 | Traditional | PDF ↗ |
| K943272 | VISUALIZER 2000 | Vf-Works, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K944973 | NRF SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1994-12-14 | Traditional | PDF ↗ |
| K943532 | PANORAMIC CORPORATION HDLX | Panoramic Corp. | 1994-12-07 | Traditional | PDF ↗ |
| K943447 | V-MAX OPTIONS | Philips Medical Systems (Cleveland), Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K943805 | PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD | General Electric Co. | 1994-09-23 | Traditional | PDF ↗ |
| K940295 | UROVIEW MODEL 2600 | Ge Dec Medical Systems | 1994-08-22 | Traditional | PDF ↗ |
| K942841 | OEC 901 | Baldwin | 1994-08-09 | Traditional | PDF ↗ |
| K942674 | ANGIOREST TABLE PAD SYSTEM | Scribner Browne Medical Design, Inc. | 1994-07-29 | Traditional | PDF ↗ |
| K942264 | DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) | Eigen Video | 1994-07-20 | Traditional | PDF ↗ |
| K941611 | TDA-4000/A4 | Toshiba America Medical Systems, In.C | 1994-05-13 | Traditional | PDF ↗ |
| K926560 | EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER | Fischer Imaging Corp. | 1994-05-09 | Traditional | PDF ↗ |
| K933472 | SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES | Shimadzu Corp. | 1994-02-07 | Traditional | PDF ↗ |
| K936136 | UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE | Ge Dec Medical Systems | 1994-01-25 | Traditional | PDF ↗ |
| K933473 | CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM | Shimadzu Corp. | 1993-11-24 | Traditional | PDF ↗ |
| K933791 | PHILIPS ANGIOPRO RELEASE 2.1 | Philips Medical Systems North America, Inc. | 1993-11-22 | Traditional | PDF ↗ |
| K934626 | GOODALL LASER TARGETING DEVICE | Protectair, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K933100 | ARC-600 | B C Medical , Ltd. | 1993-11-08 | Traditional | PDF ↗ |
| K934481 | EP-X | Fischer Imaging Corp. | 1993-11-03 | Traditional | PDF ↗ |
| K933299 | QL MULTIPULSE 2048 | Infimed, Inc. | 1993-11-03 | Traditional | PDF ↗ |
| K932445 | SIRESKOP CX | Siemens Medical Solutions USA, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K931941 | SUNSCOPE 100 | Sunning Corp. | 1993-07-20 | Traditional | PDF ↗ |
| K931268 | URETERAL COMPRESSION DEVICE | Bt Medical Co., Inc. | 1993-07-19 | Traditional | PDF ↗ |
| K930885 | PNEUMATIC COMPRESSION DEVICE | Bt Medical Co., Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K926064 | FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A | Scientific Technology , Ltd. | 1993-04-27 | Traditional | PDF ↗ |
| K926434 | SIS-300(N)-DIA SCAN | Micro-Focus Imaging., Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K926122 | FLUOREX | Toshiba America Medical Systems, In.C | 1993-02-12 | Traditional | PDF ↗ |
| K924879 | EP 3000 | Oec-Diasonics, Inc. | 1993-01-04 | Traditional | PDF ↗ |
| K925251 | LIXI IMAGING SCOPE. MODIFICATION | Lixi, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K922977 | EXPOSET | S & S Inficon, Inc. | 1992-11-27 | Traditional | PDF ↗ |
| K923107 | BODY BAND RESTRAINT STRAP SET | Cook, Inc. | 1992-11-27 | Traditional | PDF ↗ |
| K924164 | DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT | Eigen | 1992-11-23 | Traditional | PDF ↗ |
| K923585 | DIGITAL FLUORO STORE | Eigen | 1992-10-21 | Traditional | PDF ↗ |
| K922274 | MEDRAD PATHFINDER-E ROADMAPPING SYSTEM | Medrad, Inc. | 1992-10-09 | Traditional | PDF ↗ |
| K923454 | SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES | Shimadzu Medical Systems | 1992-10-05 | Traditional | PDF ↗ |
| K923453 | SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES | Shimadzu Medical Systems | 1992-10-05 | Traditional | PDF ↗ |
| K923137 | CSL X-RAY IMAGESCOPE | Csi Opto-Electronics Corp. | 1992-09-23 | Traditional | PDF ↗ |
| K922240 | ELECTRONIC PHOTOSPOT 20 | Toshiba America Medical Systems, In.C | 1992-08-07 | Traditional | PDF ↗ |
| K920746 | VFC UNIT | Tilane Corp. | 1992-06-30 | Traditional | PDF ↗ |
| K922012 | SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES | Shimadzu Medical Systems | 1992-06-16 | Traditional | PDF ↗ |
| K922011 | SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES | Shimadzu Medical Systems | 1992-06-10 | Traditional | PDF ↗ |
| K922013 | SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES | Shimadzu Medical Systems | 1992-06-10 | Traditional | PDF ↗ |
| K920720 | DIGITAL RADIOGRAPHY SYSTEM IDR-1000 | Shimadzu Medical Systems | 1992-04-20 | Traditional | PDF ↗ |
| K920721 | DIGITAL RADIOGRAPHY SYSTEM IDR-2000 | Shimadzu Medical Systems | 1992-04-15 | Traditional | PDF ↗ |
| K920550 | DISPLAY PROCESSOR - MODEL IDP5100 | Perkins Mfg. Co. | 1992-04-13 | Traditional | PDF ↗ |
| K915405 | P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS) | Precise Optics Photo Medic Equipment, Inc. | 1992-02-04 | Traditional | PDF ↗ |
| K914414 | VIDEO FLUOROSCOPE | Raymax Medical Corp. | 1992-01-24 | Traditional | PDF ↗ |
| K913886 | SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER | Sony Medical Electronics Co. | 1992-01-24 | Traditional | PDF ↗ |
| K915592 | PEGASUS LATERAL CARDIAC POSITIONER | Fischer Imaging Corp. | 1992-01-13 | Traditional | PDF ↗ |
| K914446 | UROVIEW 2000, MODIFICATION | Oec-Diasonics, Inc. | 1992-01-10 | Traditional | PDF ↗ |
| K905694 | FVP-1000 FAMILY AND FVP-1000D FAMILY | Fischer Imaging Corp. | 1991-11-27 | Traditional | PDF ↗ |
| K914525 | FLUROSPOT H VERSION 2 | Siemens Medical Solutions USA, Inc. | 1991-11-19 | Traditional | PDF ↗ |
| K913012 | DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES | Eigen | 1991-09-23 | Traditional | PDF ↗ |
| K912896 | DIGISTORE 2100 | Enhanced Imaging Technologies, Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K912341 | MULTICAM I 8X10 | Camtronics, Ltd. | 1991-08-26 | Traditional | PDF ↗ |
| K912470 | PHILIPS DIAGNOST 96 | Philips Medical Systems, Inc. | 1991-08-07 | Traditional | PDF ↗ |
| K912380 | LASER BEAM LOCALIZER FOR SIREMOBIL 4 | Siemens Medical Solutions USA, Inc. | 1991-07-19 | Traditional | PDF ↗ |
| K911454 | FC2000 | S & S Inficon, Inc. | 1991-07-15 | Traditional | PDF ↗ |
| K910384 | VIDEO ANNOTATOR MODEL PK2310 | Perkins Mfg. Co. | 1991-04-16 | Traditional | PDF ↗ |
| K905278 | STS(TM) FLUOROSCOPIC IMAGING MODULE | Medstone Intl., Inc. | 1991-02-04 | Traditional | PDF ↗ |
| K905111 | DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES | Eigen | 1991-01-25 | Traditional | PDF ↗ |
| K904986 | PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 | Perkins Mfg. Co. | 1990-12-04 | Traditional | PDF ↗ |
| K904012 | PHILIPS INTEGRIS I 2000 SYSTEM | Philips Medical Systems, Inc. | 1990-11-29 | Traditional | PDF ↗ |
| K902982 | G.E. POLARIX II C-ARM | Electromek Diagnostic Systems, Inc. | 1990-11-13 | Traditional | PDF ↗ |
| K902981 | G.E. FLUOROCON 300 IMAGING SYSTEM | Electromek Diagnostic Systems, Inc. | 1990-11-07 | Traditional | PDF ↗ |
| K903821 | PSC-1 W/OTHER NUMERICAL | Eigen | 1990-11-07 | Traditional | PDF ↗ |
| K902983 | SIEMEN'S SIREMOBILE II C-ARM | Electromek Diagnostic Systems, Inc. | 1990-11-06 | Traditional | PDF ↗ |
| K902980 | G.E. XT CEILING TUBE SUSPENSION | Electromek Diagnostic Systems, Inc. | 1990-10-23 | Traditional | PDF ↗ |
| K902583 | JOINT MOTON IMAGER(TM) | Concord Imaging, Ltd. | 1990-09-27 | Traditional | PDF ↗ |
| K902005 | MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE | Omega Medical Imaging, Inc. | 1990-09-20 | Traditional | PDF ↗ |
| K901671 | HAFCON (FLOURO FOOTSWITCH) | B & H Research Instruments | 1990-08-08 | Traditional | PDF ↗ |
| K902927 | DIGITAL PHOTOSPOT | Eigen | 1990-08-03 | Traditional | PDF ↗ |
Product code JAA · Class II · Radiology. Data: openFDA.