Cleared Traditional

APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER

K955844 · Varian Assoc., Inc. · Radiology

Jul 1996

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K955844 is an FDA 510(k) clearance for the APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE 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 July 26, 1996, 213 days after receiving the submission on December 26, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number	K955844 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 1995
Decision Date	July 26, 1996
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF