Clearance Summary
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) received FDA 510(k) clearance under submission number K230221, sponsored by Versant Medical Physics and Radiation Safety. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-08-28.
- Submission: K230221
- Applicant / Sponsor: Versant Medical Physics and Radiation Safety
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2023-08-28
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.