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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 the device name listed in this FDA 510(k) record. The listed applicant is Versant Medical Physics and Radiation Safety. It received FDA 510(k) clearance on 2023-08-28 under 510(k) 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. The listed applicant is Versant Medical Physics and Radiation Safety. The 510(k) number is K230221.

When did QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) receive FDA 510(k) clearance?

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

Who is the listed applicant for QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)?

The FDA 510(k) record lists Versant Medical Physics and Radiation Safety as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: IYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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