IZJ
12 FDA 510(k) clearances · Product code
50 daysmedian time to decision
125 days90th percentile
12clearances measured
FDA profile
- Official device name
- Camera, X-Ray, Fluorographic, Cine Or Spot
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1620
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1995: 1 · 1996: 1 · 1998: 3 · 2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CCD CAMERA, MODEL PKP-06000-000 (K024085) | Perkins Electronics Co. | 2003-03-11 |
| DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR (K972130) | Fairmontmedical | 1997-10-09 |
| DSP OPTION (K945580) | Philips Medical Systems (Cleveland), Inc. | 1995-01-30 |
| PHILIPS DSI SYSTEM RELEASE 3.2 (K920793) | Philips Medical Systems, Inc. | 1992-07-17 |
| CINE CAMERA CONTROL MODEL PK2037 (K896615) | Perkins Mfg. Co. | 1990-01-04 |
| DTV-4114 FLUOROSCOPIC TELEVISION CAMERA (K881688) | Adac Laboratories | 1988-05-18 |
| CANON X-RAY 35MM CINE CAMERA CSI-35 (K853983) | Canon USA, Inc. | 1985-10-16 |
| VIDICAM 200 (K812613) | Diversified P.A. | 1981-12-08 |
| SIRCAM 103 (K810191) | Siemens Corp. | 1981-02-26 |
| 105MM ROLL FILM FLUOROGR. CAMERA, #105 (K810072) | Scientex Corp. | 1981-02-12 |
| 105MM SPOT FILM CAMERA (K802132) | Instrumentation Camera, Inc. | 1980-10-23 |
| SIRCAM 106 (K792394) | Siemens Corp. | 1979-12-20 |
Track IZJ automatically
Every clearance here is in the API, with alerts when new ones post.