Name: Predicase
Price: 199 USD

K-number	K213438
Device name	3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
Applicant	Adaptiiv
Product code	MUJ
Device class	Class II
Decision date	Jan 19, 2022
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory

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