K837378 is an FDA 510(k) clearance for the OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM..
Submitted by Omnimedical (Mchenry, US). The FDA issued a Cleared decision on May 18, 1983, 62 days after receiving the submission on March 17, 1983.
This device falls under the Radiology FDA review panel.
| 510(k) Number | K837378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1983 |
| Decision Date | May 18, 1983 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | — |
| Device Class | — |