FDA product code IWZ: Film, Radiographic
IWZ is the FDA product code for film, radiographic. It is a Class I device, regulated under 21 CFR 892.1840 and reviewed by the Radiology panel. FDA has cleared 34 510(k) submissions under IWZ, from 13 different applicants. The average 510(k) review took 53 days (median 49). FDA has posted 13 recalls for IWZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Film, Radiographic |
| Device class | Class I |
| Regulation | 21 CFR 892.1840 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IWZ clearance
Top IWZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 17 | 1997-04-04 |
| Cea America Corp. | 4 | 1984-03-05 |
| 3M Health Care, Ltd. | 2 | 1993-07-21 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 1983-09-12 |
| Voxel | 1 | 1995-09-29 |
8 more applicants have IWZ clearances. See the full list in Caduvo.
Most recent IWZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970154 | Eastman Kodak Company | KODAK EKTASIAN HG FILM (EHG-15) | 1997-04-04 | 78 |
| K954200 | Voxel | VOXGRAM | 1995-09-29 | 23 |
| K931604 | 3M Health Care, Ltd. | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE | 1993-07-21 | 111 |
| K931605 | 3M Health Care, Ltd. | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE | 1993-07-20 | 110 |
| K920539 | Burkhart Roentgen Intl., Inc. | ORWO X-RAY FILM | 1992-06-30 | 146 |
Recalls for IWZ devices
13 product recalls in 11 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-01-25.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code IWZ?
IWZ is the FDA product code for film, radiographic. It is a Class I device, regulated under 21 CFR 892.1840 and reviewed by the Radiology panel.
What device class is IWZ?
Class I, regulation 21 CFR 892.1840. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWZ?
Across 34 cleared submissions the average was 53 days from receipt to decision (median 49).
Which companies have the most IWZ clearances?
Eastman Kodak Company (17); Cea America Corp. (4); 3M Health Care, Ltd. (2); E.I. Dupont DE Nemours & Co., Inc. (2); Voxel (1).
Have IWZ devices been recalled?
Yes: 13 product recalls across 11 recall events; the most recent began 2019-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code IWZ
- Run a recall and safety report across every IWZ manufacturer
- Watch product code IWZ 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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