Submission Details
| 510(k) Number | K827065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 1982 |
| Decision Date | February 18, 1982 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |