K221932 is an FDA 510(k) clearance for the Omni Legend. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on September 2, 2022, 63 days after receiving the submission on July 1, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K221932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2022 |
| Decision Date | September 02, 2022 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPS — System, Tomography, Computed, Emission |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1200 |