Cleared Traditional

VSP Bolus

K214093 · 3D Systems · Radiology
Mar 2022
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K214093 is an FDA 510(k) clearance for the VSP Bolus, a Block, Beam-shaping, Radiation Therapy (Class II — Special Controls, product code IXI), submitted by 3D Systems (Littleton, US). The FDA issued a Cleared decision on March 30, 2022, 92 days after receiving the submission on December 28, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5710.

Submission Details

510(k) Number K214093 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2021
Decision Date March 30, 2022
Days to Decision 92 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