Cleared Traditional

PROTON VISION

K000922 · Varian Assoc., Inc. · Radiology
May 2000
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K000922 is an FDA 510(k) clearance for the PROTON VISION, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 24, 2000, 63 days after receiving the submission on March 22, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K000922 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2000
Decision Date May 24, 2000
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050