Cleared Traditional

VARIAN ORIGAMI, VERSION 1.0

K932501 · Varian Assoc., Inc. · Radiology
Sep 1994
Decision
486d
Days
Class 2
Risk

About This 510(k) Submission

K932501 is an FDA 510(k) clearance for the VARIAN ORIGAMI, VERSION 1.0, 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, 486 days after receiving the submission on May 25, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K932501 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 1993
Decision Date September 23, 1994
Days to Decision 486 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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