IZJ · Camera, X-Ray, Fluorographic, Cine Or Spot
Radiology · 21 CFR 892.1620 · Class 2
Overview
| Product Code | IZJ |
|---|---|
| Device Name | Camera, X-Ray, Fluorographic, Cine Or Spot |
| Regulation | 21 CFR 892.1620 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.
Classification Rationale
Class II.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K024085 | CCD CAMERA, MODEL PKP-06000-000 | Perkins Electronics Co. | Mar 11, 2003 | SESE |
| K972130 | DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR | Fairmontmedical | Oct 9, 1997 | SESE |
| K945580 | DSP OPTION | Philips Medical Systems (Cleveland), Inc. | Jan 30, 1995 | SESE |
| K920793 | PHILIPS DSI SYSTEM RELEASE 3.2 | Philips Medical Systems, Inc. | Jul 17, 1992 | SESE |
| K896615 | CINE CAMERA CONTROL MODEL PK2037 | Perkins Mfg. Co. | Jan 4, 1990 | SESE |
| K881688 | DTV-4114 FLUOROSCOPIC TELEVISION CAMERA | Adac Laboratories | May 18, 1988 | SESE |
| K853983 | CANON X-RAY 35MM CINE CAMERA CSI-35 | Canon USA, Inc. | Oct 16, 1985 | SESE |
| K812613 | VIDICAM 200 | Diversified P.A. | Dec 8, 1981 | SESE |
| K810191 | SIRCAM 103 | Siemens Corp. | Feb 26, 1981 | SESE |
| K810072 | 105MM ROLL FILM FLUOROGR. CAMERA, #105 | Scientex Corp. | Feb 12, 1981 | SESE |
| K802132 | 105MM SPOT FILM CAMERA | Instrumentation Camera, Inc. | Oct 23, 1980 | SESE |
| K792394 | SIRCAM 106 | Siemens Corp. | Dec 20, 1979 | SESE |
Top Applicants
- Siemens Corp. — 2 clearances
- Scientex Corp. — 1 clearance
- Philips Medical Systems, Inc. — 1 clearance
- Philips Medical Systems (Cleveland), Inc. — 1 clearance
- Perkins Mfg. Co. — 1 clearance
