QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)— 510(k) K230221
Substantially EquivalentVersant Medical Physics and Radiation Safety
FDA 510(k) clearance K230221 for QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy), Substantially Equivalent on 2023-08-28. Applicant: Versant Medical Physics and Radiation Safety. Device class: 1.
Clearance details
- Applicant
- Versant Medical Physics and Radiation Safety
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
Recent devices under product code IYX
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