Name: Predicase
Price: 199 USD

K-number	K230221
Device name	QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
Applicant	Versant Medical Physics and Radiation Safety
Product code	IYX
Device class	Class I
Decision date	Aug 28, 2023
Decision	Substantially Equivalent
Regulation	892.1100

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.