Camera, X-Ray, Fluorographic, Cine Or Spot
Regulation 892.1620
0510(k)s in 12 months (12 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in IZJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Philips Medical Systems (Cleveland), Inc. | 1 | 1 |
| Siemens Corp. | 2 | 0 |
| Adac Laboratories | 1 | 0 |
| Canon USA, Inc. | 1 | 0 |
| Diversified P.A. | 1 | 0 |
| Fairmontmedical | 1 | 0 |
| Instrumentation Camera, Inc. | 1 | 0 |
| Perkins Electronics Co. | 1 | 0 |
| Perkins Mfg. Co. | 1 | 0 |
| Philips Medical Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 2003 | K024085 | CCD CAMERA, MODEL PKP-06000-000 Perkins Electronics Co. | IZJ |
| Oct 9, 1997 | K972130 | DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR Fairmontmedical, AU | IZJ |
| Jan 30, 1995 | K945580 | DSP OPTION Philips Medical Systems (Cleveland), Inc. | IZJ |
| Jul 17, 1992 | K920793 | PHILIPS DSI SYSTEM RELEASE 3.2 Philips Medical Systems, Inc., NL | IZJ |
| Jan 4, 1990 | K896615 | CINE CAMERA CONTROL MODEL PK2037 Perkins Mfg. Co. | IZJ |
| May 18, 1988 | K881688 | DTV-4114 FLUOROSCOPIC TELEVISION CAMERA Adac Laboratories | IZJ |
| Oct 16, 1985 | K853983 | CANON X-RAY 35MM CINE CAMERA CSI-35 Canon USA, Inc. | IZJ |
| Dec 8, 1981 | K812613 | VIDICAM 200 Diversified P.A. | IZJ |
| Feb 26, 1981 | K810191 | SIRCAM 103 Siemens Corp. | IZJ |
| Feb 12, 1981 | K810072 | 105MM ROLL FILM FLUOROGR. CAMERA, #105 Scientex Corp. | IZJ |
| Oct 23, 1980 | K802132 | 105MM SPOT FILM CAMERA Instrumentation Camera, Inc. | IZJ |
| Dec 20, 1979 | K792394 | SIRCAM 106 Siemens Corp. | IZJ |
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