Cleared Traditional

CADPLAN BT

K954467 · Varian Assoc., Inc. · Radiology
Mar 1996
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K954467 is an FDA 510(k) clearance for the CADPLAN BT, 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 March 15, 1996, 171 days after receiving the submission on September 26, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K954467 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1995
Decision Date March 15, 1996
Days to Decision 171 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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