K801027 is an FDA 510(k) clearance for the MDS IMAGER..
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on May 28, 1980, 27 days after receiving the submission on May 1, 1980.
This device falls under the Radiology FDA review panel.
| 510(k) Number | K801027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1980 |
| Decision Date | May 28, 1980 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | — |
| Device Class | — |