FDA product code IXX: Processor, Cine Film
IXX is the FDA product code for processor, cine film. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel. FDA has cleared 6 510(k) submissions under IXX, from 3 different applicants. The average 510(k) review took 85 days (median 55).
Classification
| Field | Value |
|---|---|
| Device name | Processor, Cine Film |
| Device class | Class II |
| Regulation | 21 CFR 892.1900 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXX clearance
Top IXX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Allen Products Co. | 3 | 1992-08-27 |
| Jamieson Film Co. | 2 | 1996-09-11 |
| Anago, Inc. | 1 | 1986-06-09 |
Most recent IXX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963334 | Jamieson Film Co. | JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 | 1996-09-11 | 16 |
| K915365 | The Allen Products Co. | AP-6CR CINERADIOGRAPHIC FILM PROCESSOR | 1992-08-27 | 274 |
| K913241 | Jamieson Film Co. | JAMIESON JT-CRP CINE FILM PROCESSOR | 1991-09-24 | 64 |
| K861928 | Anago, Inc. | STERILE O. R. TOWEL | 1986-06-09 | 20 |
| K850421 | The Allen Products Co. | CINE RADIOGRAPHIC FILM PROCESSOR M-45CR | 1985-03-22 | 46 |
Recalls for IXX devices
openFDA lists no recalls for product code IXX.
Frequently asked questions
What is FDA product code IXX?
IXX is the FDA product code for processor, cine film. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel.
What device class is IXX?
Class II, regulation 21 CFR 892.1900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXX?
Across 6 cleared submissions the average was 85 days from receipt to decision (median 55).
Which companies have the most IXX clearances?
The Allen Products Co. (3); Jamieson Film Co. (2); Anago, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IXX
- Run a recall and safety report across every IXX manufacturer
- Watch product code IXX 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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