IZJ — Camera, X-Ray, Fluorographic, Cine Or Spot Class II
FDA product code IZJ covers "Camera, X-Ray, Fluorographic, Cine Or Spot", a Class II medical device regulated under 21 CFR 892.1620. Submissions are reviewed by the Radiology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IZJ
- Device Class
- Class II
- Regulation Number
- 892.1620
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K024085 | perkins electronics | CCD CAMERA, MODEL PKP-06000-000 | March 11, 2003 |
| K972130 | fairmontmedical | DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSAB | October 9, 1997 |
| K945580 | philips medical systems (cleveland) | DSP OPTION | January 30, 1995 |
| K920793 | philips medical systems | PHILIPS DSI SYSTEM RELEASE 3.2 | July 17, 1992 |
| K896615 | perkins mfg | CINE CAMERA CONTROL MODEL PK2037 | January 4, 1990 |
| K881688 | adac laboratories | DTV-4114 FLUOROSCOPIC TELEVISION CAMERA | May 18, 1988 |
| K853983 | canon usa | CANON X-RAY 35MM CINE CAMERA CSI-35 | October 16, 1985 |
| K812613 | diversified p.a | VIDICAM 200 | December 8, 1981 |
| K810191 | siemens | SIRCAM 103 | February 26, 1981 |
| K810072 | scientex | 105MM ROLL FILM FLUOROGR. CAMERA, #105 | February 12, 1981 |
| K802132 | instrumentation camera | 105MM SPOT FILM CAMERA | October 23, 1980 |
| K792394 | siemens | SIRCAM 106 | December 20, 1979 |