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FDA 510(k)

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)

K-Number: K230221 · 2023-08-28

ApplicantVersant Medical Physics and Radiation Safety
Decision Date2023-08-28
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) is a medical device manufactured by Versant Medical Physics and Radiation Safety. It received FDA 510(k) clearance on 2023-08-28 under approval number K230221. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)?

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) is a medical device that received FDA 510(k) clearance on 2023-08-28. It is manufactured by Versant Medical Physics and Radiation Safety. The 510(k) number is K230221.

When was QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) approved by the FDA?

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) received FDA 510(k) clearance on 2023-08-28, under approval number K230221.

What company makes QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)?

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) is manufactured by Versant Medical Physics and Radiation Safety.

What is the FDA product code for QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)?

The FDA product code for QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) is IYX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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