K943602 is an FDA 510(k) clearance for the DI-2000. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by Miles Inc., Agfa Division (Ridgefield Park, US). The FDA issued a Cleared decision on May 12, 1995, 291 days after receiving the submission on July 25, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K943602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1994 |
| Decision Date | May 12, 1995 |
| Days to Decision | 291 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IYX — Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |