FDA product code IXA: Cassette, Radiographic Film
IXA is the FDA product code for cassette, radiographic film. It is a Class II device, regulated under 21 CFR 892.1850 and reviewed by the Radiology panel. FDA has cleared 51 510(k) submissions under IXA, from 31 different applicants. The average 510(k) review took 70 days (median 47). FDA has posted 1 recall for IXA devices.
Classification
| Field | Value |
|---|---|
| Device name | Cassette, Radiographic Film |
| Device class | Class II |
| Regulation | 21 CFR 892.1850 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXA clearance
Top IXA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 13 | 2004-05-24 |
| E.I. Dupont DE Nemours & Co., Inc. | 6 | 1995-09-06 |
| Mci Optonix, Inc. | 2 | 1995-08-02 |
| Fujifilm Medical System U.S.A., Inc. | 2 | 1994-07-29 |
| Dupont Medical Products | 2 | 1994-07-20 |
26 more applicants have IXA clearances. See the full list in Caduvo.
Most recent IXA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081557 | Jddb Manufacturing, Inc. | PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER | 2008-09-10 | 99 |
| K053173 | Konica Minolta Medical & Graphic, Inc. | DS CASSETTE | 2005-12-15 | 31 |
| K040378 | Eastman Kodak Company | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | 2004-05-24 | 97 |
| K023020 | Agfa Corp. | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE | 2002-09-26 | 15 |
| K021903 | Eastman Kodak Company | KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE | 2002-07-10 | 30 |
Recalls for IXA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-01-26.
Frequently asked questions
What is FDA product code IXA?
IXA is the FDA product code for cassette, radiographic film. It is a Class II device, regulated under 21 CFR 892.1850 and reviewed by the Radiology panel.
What device class is IXA?
Class II, regulation 21 CFR 892.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXA?
Across 51 cleared submissions the average was 70 days from receipt to decision (median 47).
Which companies have the most IXA clearances?
Eastman Kodak Company (13); E.I. Dupont DE Nemours & Co., Inc. (6); Mci Optonix, Inc. (2); Fujifilm Medical System U.S.A., Inc. (2); Dupont Medical Products (2).
Have IXA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-01-26.
Next steps
- Run an FDA pathway report with predicate devices for product code IXA
- Run a recall and safety report across every IXA manufacturer
- Watch product code IXA 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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