K901013 is an FDA 510(k) clearance for the RADIOGRAPHIC FILM CASSETTE. This device is classified as a Cassette, Radiographic Film (Class II - Special Controls, product code IXA).
Submitted by Infab Corp. (Camarillo, US). The FDA issued a Cleared decision on March 28, 1990, 23 days after receiving the submission on March 5, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1850.
| 510(k) Number | K901013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1990 |
| Decision Date | March 28, 1990 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IXA — Cassette, Radiographic Film |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1850 |