K942883 is an FDA 510(k) clearance for the DIGITAL I.D. CAMERA. This device is classified as a System, X-ray, Film Marking, Radiographic (Class I - General Controls, product code JAC).
Submitted by Miles Inc., Agfa Division (Ridgefield Park, US). The FDA issued a Cleared decision on September 30, 1994, 105 days after receiving the submission on June 17, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1640.
| 510(k) Number | K942883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1994 |
| Decision Date | September 30, 1994 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | JAC — System, X-ray, Film Marking, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1640 |