K230221 is an FDA 510(k) clearance for the QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy). This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by Versant Medical Physics and Radiation Safety (Kalamazoo, US). The FDA issued a Cleared decision on August 28, 2023, 214 days after receiving the submission on January 26, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K230221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2023 |
| Decision Date | August 28, 2023 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYX - Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |