Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1620](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1620) → IZJ — Camera, X-Ray, Fluorographic, Cine Or Spot

# IZJ · Camera, X-Ray, Fluorographic, Cine Or Spot

_Radiology · 21 CFR 892.1620 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ

## Overview

- **Product Code:** IZJ
- **Device Name:** Camera, X-Ray, Fluorographic, Cine Or Spot
- **Regulation:** [21 CFR 892.1620](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1620)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K024085.md) | CCD CAMERA, MODEL PKP-06000-000 | Perkins Electronics Co. | Mar 11, 2003 | SESE |
| [K972130](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K972130.md) | DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR | Fairmontmedical | Oct 9, 1997 | SESE |
| [K945580](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K945580.md) | DSP OPTION | Philips Medical Systems (Cleveland), Inc. | Jan 30, 1995 | SESE |
| [K920793](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K920793.md) | PHILIPS DSI SYSTEM RELEASE 3.2 | Philips Medical Systems, Inc. | Jul 17, 1992 | SESE |
| [K896615](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K896615.md) | CINE CAMERA CONTROL MODEL PK2037 | Perkins Mfg. Co. | Jan 4, 1990 | SESE |
| [K881688](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K881688.md) | DTV-4114 FLUOROSCOPIC TELEVISION CAMERA | Adac Laboratories | May 18, 1988 | SESE |
| [K853983](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K853983.md) | CANON X-RAY 35MM CINE CAMERA CSI-35 | Canon USA, Inc. | Oct 16, 1985 | SESE |
| [K812613](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K812613.md) | VIDICAM 200 | Diversified P.A. | Dec 8, 1981 | SESE |
| [K810191](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K810191.md) | SIRCAM 103 | Siemens Corp. | Feb 26, 1981 | SESE |
| [K810072](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K810072.md) | 105MM ROLL FILM FLUOROGR. CAMERA, #105 | Scientex Corp. | Feb 12, 1981 | SESE |
| [K802132](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K802132.md) | 105MM SPOT FILM CAMERA | Instrumentation Camera, Inc. | Oct 23, 1980 | SESE |
| [K792394](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K792394.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ)

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