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510(k) K230221

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) by Versant Medical Physics and Radiation Safety — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2023
Date Received
January 26, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

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