Cleared Traditional

SOMAVISION

K992751 · Varian Assoc., Inc. · Radiology
Feb 2000
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K992751 is an FDA 510(k) clearance for the SOMAVISION, a System, Simulation, Radiation Therapy (Class II — Special Controls, product code KPQ), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 16, 2000, 184 days after receiving the submission on August 16, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number K992751 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1999
Decision Date February 16, 2000
Days to Decision 184 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPQ — System, Simulation, Radiation Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5840

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