Submission Details
| 510(k) Number | K873038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1987 |
| Decision Date | April 03, 1989 |
| Days to Decision | 608 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |