Camera, Scintillation (Gamma)
Regulation 892.1100
0510(k)s in 12 months (130 all time)
2recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in IYX
| Company | 510(k)s | Recalls |
|---|---|---|
| General Electric Co. | 15 | 0 |
| Siemens Gammasonics, Inc. | 11 | 0 |
| Adac Laboratories | 6 | 0 |
| Elscint, Inc. | 5 | 0 |
| Medtronic Vascular | 5 | 0 |
| Toshiba Medical Systems | 5 | 0 |
| Medx, Inc. | 4 | 0 |
| Union Carbide Corp. | 4 | 0 |
| Digirad Corp. | 3 | 0 |
| Dilon Technologies, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 1991 | K905074 | MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM Siemens Gammasonics, Inc. | IYX |
| Apr 18, 1991 | K911346 | SOPHYCAMERA DSX BODYTRAK Sopha Medical Systems, Inc. | IYX |
| Mar 25, 1991 | K905412 | ES/ULTRA DISPLAY AND PROCESSING STATION Toshiba America Medical Systems, In.C | IYX |
| Feb 4, 1991 | K903469 | GAMMA 600 NUCLEAR MEDICINE COMPUTER Strichman Medical Equipment, Inc. | IYX |
| Jan 28, 1991 | K905827 | FULL VIEW OMEGA TABLE Med-Tron Products, Inc. | IYX |
| Jan 4, 1991 | K904174 | STARCAM 4000 General Electric Co. | IYX |
| Dec 5, 1990 | K904050 | MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA Philips Medical Systems (Cleveland), Inc. | IYX |
| Oct 29, 1990 | K903030 | SOPHYCAMERA DSM 315 Provino, DK | IYX |
| Oct 23, 1990 | K903988 | PANORAMIC OMEGA IMAGING TABLE Med-Tron Products, Inc. | IYX |
| May 23, 1990 | K900773 | NUCLEAR MAX Scientific Imaging, Inc. | IYX |
| Apr 19, 1990 | K900689 | MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA Adac Laboratories | IYX |
| Oct 27, 1989 | K894931 | SOPHYCAMERA DSX RECTANGULAR Sopha Medical Systems, Inc. | IYX |
| Aug 11, 1989 | K893379 | XENOS MOBILECAM Xenos Medical Systems, Inc. | IYX |
| Apr 19, 1989 | K885054 | SYSTEM SEVENTY SEVEN Scinticor, Inc. | IYX |
| Apr 17, 1989 | K884675 | APEX 609R ANGER CAMERA Elscint, Inc. | IYX |
| Apr 17, 1989 | K884674 | APEX 415 ANGER CAMERA Elscint, Inc. | IYX |
| Apr 17, 1989 | K884672 | APEX 115 NUCLEAR MEDICINE PROCESSOR Elscint, Inc. | IYX |
| Apr 14, 1989 | K884673 | APEX 215M MOBILE ANGER CAMERA Elscint, Inc. | IYX |
| Apr 12, 1989 | K884661 | D-SCOPE III Medx, Inc. | IYX |
| Mar 30, 1989 | K885242 | MICRODELTA II Siemens Gammasonics, Inc. | IYX |
| Sep 1, 1988 | K880878 | CX250 MOBILE GAMMA CAMERA & DCS CONSOLE Philips Medical Systems (Cleveland), Inc. | IYX |
| Aug 29, 1988 | K881013 | MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A Toshiba Medical Systems | IYX |
| Jul 14, 1988 | K882312 | MODEL 3000 NUCLEAR CAMERA Ohio Imaging, Inc. | IYX |
| Jul 1, 1988 | K875198 | DIGITAL NUCLEAR IMAGING SYSTEM Medasys, Inc. | IYX |
| Aug 12, 1987 | K872297 | DS-7 NUCLEAR MEDICINE GAMMA CAMERA Sopha Medical Systems, Inc. | IYX |
| Jun 18, 1987 | K872127 | D-SCOPE II AND D-SCOPE IIC Medx, Inc. | IYX |
| Mar 31, 1987 | K871175 | JUMBO DIGITAL GAMMACAMERA, GCA-901A Toshiba Medical Systems | IYX |
| Mar 16, 1987 | K870818 | BODYSCAN Siemens Gammasonics, Inc. | IYX |
| Feb 26, 1987 | K870703 | SKAN D-SCOPE Medx, Inc. | IYX |
| Jun 10, 1986 | K861637 | WEIGHTED ACQUISITION MODULE Siemens Gammasonics, Inc. | IYX |
| Jan 30, 1986 | K852648 | STARPORT MODEL H3300AA General Electric Co. | IYX |
| Jan 1, 1986 | K853482 | ACE COMPUTER SYSTEM Cardiac Medical Systems Corp. | IYX |
| Nov 19, 1985 | K853470 | JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 Toshiba Medical Systems | IYX |
| Jul 18, 1985 | K852089 | SATURN NUCLEAR MEDICINE COMPUTER SYSTEM Technicare Corp. | IYX |
| May 21, 1985 | K851644 | SPECTRUM 150 DT Raytheon Medical Systems | IYX |
| Apr 10, 1985 | K850463 | BASICAM COUNTER BALANCE CAMERA Siemens Gammasonics, Inc. | IYX |
| Mar 26, 1985 | K850397 | ORBITOR II COUNTER BALANCE CAMERA Siemens Gammasonics, Inc. | IYX |
| Mar 1, 1985 | K844218 | TOMOGRAPHIC GANTRY General Electric Co. | IYX |
| Dec 17, 1984 | K843716 | NUCLEAR 700 MEDICINE MECHANICAL POSIT- Technicare Corp. | IYX |
| Nov 13, 1984 | K843558 | DELTANODE, MEGA DELTA, DELTA LINK- Computer Design & Applications, Inc. | IYX |
| Nov 8, 1984 | K843288 | KETRONIC MEDAX - N Ketronic, Inc. | IYX |
| Aug 21, 1984 | K841964 | MICRO DELTA & CELTAPRO Computer Design & Applications, Inc. | IYX |
| Jul 6, 1984 | K841906 | MAXICAMERA 400 AC General Electric Co. | IYX |
| Mar 22, 1984 | K840052 | DIGITAL PROCESSING SYSTEM Adac Laboratories | IYX |
| Jan 13, 1984 | K833821 | INTERAD 520 Interad Systems, Inc. | IYX |
| Dec 27, 1983 | K833811 | CARDIAC CAMERA Siemens Gammasonics, Inc. | IYX |
| Sep 12, 1983 | K832505 | IMAGE PROCESSING SYS A3 Metronic, Inc. | IYX |
| Mar 2, 1982 | K820244 | ADD'L TERMINAL SUPPORT FOR STAR BASIC General Electric Co. | IYX |
| Dec 8, 1981 | K813073 | OMEGA 500 RECTANGULAR FIELD CAMERA W/SC Technicare Corp. | IYX |
| Sep 8, 1981 | K811629 | DYNA- MO Philips Medical Systems (Cleveland), Inc. | IYX |
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