Cleared Special

CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM

K992753 · Varian Assoc., Inc. · Radiology
Sep 1999
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K992753 is an FDA 510(k) clearance for the CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM, 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 September 3, 1999, 18 days after receiving the submission on August 16, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K992753 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1999
Decision Date September 03, 1999
Days to Decision 18 days
Submission Type Special
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