Cleared Traditional

APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER

K952913 · Varian Assoc., Inc. · Radiology

Nov 1995

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K952913 is an FDA 510(k) clearance for the APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on November 22, 1995, 149 days after receiving the submission on June 26, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number	K952913 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 1995
Decision Date	November 22, 1995
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF