Cleared Traditional

VARIAN RMS-2000, RELEASE 2.5

K930513 · Varian Assoc., Inc. · Radiology
Sep 1994
Decision
599d
Days
Class 2
Risk

About This 510(k) Submission

K930513 is an FDA 510(k) clearance for the VARIAN RMS-2000, RELEASE 2.5, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on September 23, 1994, 599 days after receiving the submission on February 1, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K930513 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1993
Decision Date September 23, 1994
Days to Decision 599 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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