FDA product code IZJ: Camera, X-Ray, Fluorographic, Cine Or Spot
IZJ is the FDA product code for camera, x-ray, fluorographic, cine or spot. It is a Class II device, regulated under 21 CFR 892.1620 and reviewed by the Radiology panel. FDA has cleared 12 510(k) submissions under IZJ, from 11 different applicants. The average 510(k) review took 63 days (median 47). FDA has posted 2 recalls for IZJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Camera, X-Ray, Fluorographic, Cine Or Spot |
| Device class | Class II |
| Regulation | 21 CFR 892.1620 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every IZJ clearance
Top IZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Corp. | 2 | 1981-02-26 |
| Perkins Electronics Co. | 1 | 2003-03-11 |
| Fairmontmedical | 1 | 1997-10-09 |
| Philips Medical Systems (Cleveland), Inc. | 1 | 1995-01-30 |
| Philips Medical Systems, Inc. | 1 | 1992-07-17 |
6 more applicants have IZJ clearances. See the full list in Caduvo.
Most recent IZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K024085 | Perkins Electronics Co. | CCD CAMERA, MODEL PKP-06000-000 | 2003-03-11 | 90 |
| K972130 | Fairmontmedical | DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR | 1997-10-09 | 125 |
| K945580 | Philips Medical Systems (Cleveland), Inc. | DSP OPTION | 1995-01-30 | 77 |
| K920793 | Philips Medical Systems, Inc. | PHILIPS DSI SYSTEM RELEASE 3.2 | 1992-07-17 | 147 |
| K896615 | Perkins Mfg. Co. | CINE CAMERA CONTROL MODEL PK2037 | 1990-01-04 | 44 |
Recalls for IZJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-12-04.
Frequently asked questions
What is FDA product code IZJ?
IZJ is the FDA product code for camera, x-ray, fluorographic, cine or spot. It is a Class II device, regulated under 21 CFR 892.1620 and reviewed by the Radiology panel.
What device class is IZJ?
Class II, regulation 21 CFR 892.1620. Typical premarket route: 510(k).
How long does a 510(k) take for product code IZJ?
Across 12 cleared submissions the average was 63 days from receipt to decision (median 47).
Which companies have the most IZJ clearances?
Siemens Corp. (2); Perkins Electronics Co. (1); Fairmontmedical (1); Philips Medical Systems (Cleveland), Inc. (1); Philips Medical Systems, Inc. (1).
Have IZJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-12-04.
Next steps
- Run an FDA pathway report with predicate devices for product code IZJ
- Run a recall and safety report across every IZJ manufacturer
- Watch product code IZJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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