K782047 is an FDA 510(k) clearance for the PROCESSING SYSTEM, A2 IMAGE. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on December 20, 1978, 12 days after receiving the submission on December 8, 1978.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K782047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1978 |
| Decision Date | December 20, 1978 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IYX — Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |