K827408 is an FDA 510(k) clearance for the ULTRA IMAGER..
Submitted by Honeywell, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 4, 1982, 68 days after receiving the submission on July 28, 1982.
This device falls under the Radiology FDA review panel.
| 510(k) Number | K827408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1982 |
| Decision Date | October 04, 1982 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | — |
| Device Class | — |