K862944 is an FDA 510(k) clearance for the KODAK CFT FILM SO-141. This device is classified as a Film, Radiographic (Class I - General Controls, product code IWZ).
Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 12, 1986, 7 days after receiving the submission on August 5, 1986.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1840.
| 510(k) Number | K862944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1986 |
| Decision Date | August 12, 1986 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWZ — Film, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1840 |