IXX
6 FDA 510(k) clearances · Product code
64 daysmedian time to decision
274 days90th percentile
6clearances measured
FDA profile
- Official device name
- Processor, Cine Film
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1900
- Medical specialty
- Radiology
- Adverse events (MAUDE)
- 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 (K963334) | Jamieson Film Co. | 1996-09-11 |
| AP-6CR CINERADIOGRAPHIC FILM PROCESSOR (K915365) | The Allen Products Co. | 1992-08-27 |
| JAMIESON JT-CRP CINE FILM PROCESSOR (K913241) | Jamieson Film Co. | 1991-09-24 |
| STERILE O. R. TOWEL (K861928) | Anago, Inc. | 1986-06-09 |
| CINE RADIOGRAPHIC FILM PROCESSOR M-45CR (K850421) | The Allen Products Co. | 1985-03-22 |
| RADIOGRAPHIC FILM PROCESSOR M-30CR & (K841431) | The Allen Products Co. | 1984-07-06 |
Track IXX automatically
Every clearance here is in the API, with alerts when new ones post.