K222639 is an FDA 510(k) clearance for the VHA Radiotherapy Bolus. This device is classified as a Block, Beam-shaping, Radiation Therapy (Class II - Special Controls, product code IXI).
Submitted by Vha Dean (Washington, US). The FDA issued a Cleared decision on November 4, 2022, 64 days after receiving the submission on September 1, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5710.
| 510(k) Number | K222639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXI - Block, Beam-shaping, Radiation Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5710 |