DeviceClearance

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory— 510(k) K213438

Substantially Equivalent

Adaptiiv

FDA 510(k) clearance K213438 for 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory, Substantially Equivalent on 2022-01-19. Applicant: Adaptiiv. Device class: 2.

Clearance details

Applicant
Adaptiiv
Product code
Product code MUJ
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Halifax, CA
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