Cleared Traditional

VHA Radiotherapy Bolus

K222639 · Vha Dean · Radiology
Nov 2022
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K222639 is an FDA 510(k) clearance for the VHA Radiotherapy Bolus, a Block, Beam-shaping, Radiation Therapy (Class II — Special Controls, product code IXI), submitted by Vha Dean (Washington, US). The FDA issued a Cleared decision on November 4, 2022, 64 days after receiving the submission on September 1, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5710.

Submission Details

510(k) Number K222639 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2022
Decision Date November 04, 2022
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXI — Block, Beam-shaping, Radiation Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5710