K963913 is an FDA 510(k) clearance for the MD100 & MM150. This device is classified as a Screen, Intensifying, Radiographic (Class I - General Controls, product code EAM).
Submitted by Konica Medical Corp. (New York, US). The FDA issued a Cleared decision on October 8, 1997, 373 days after receiving the submission on September 30, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1960.
| 510(k) Number | K963913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1996 |
| Decision Date | October 08, 1997 |
| Days to Decision | 373 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EAM — Screen, Intensifying, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1960 |