Cleared Traditional

BRACHYVISION 6.0

K992762 · Varian Assoc., Inc. · Radiology
Mar 2000
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K992762 is an FDA 510(k) clearance for the BRACHYVISION 6.0, 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 March 9, 2000, 205 days after receiving the submission on August 17, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K992762 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1999
Decision Date March 09, 2000
Days to Decision 205 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