K220402 is an FDA 510(k) clearance for the VirtuOst. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by O.N. Diagnostics (Berkeley, US). The FDA issued a Cleared decision on May 19, 2023, 462 days after receiving the submission on February 11, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K220402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2022 |
| Decision Date | May 19, 2023 |
| Days to Decision | 462 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KGI - Densitometer, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1170 |