Cleared Traditional

HIGH DOSE RATE AFTERLOADER

K945383 · Varian Assoc., Inc. · Radiology
Feb 1995
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K945383 is an FDA 510(k) clearance for the 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 February 15, 1995, 113 days after receiving the submission on October 25, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K945383 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1994
Decision Date February 15, 1995
Days to Decision 113 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

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