Cleared Traditional

VARIS PORTALVISION

K955774 · Varian Assoc., Inc. · Radiology
Mar 1996
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K955774 is an FDA 510(k) clearance for the VARIS PORTALVISION, 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 March 15, 1996, 85 days after receiving the submission on December 21, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K955774 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1995
Decision Date March 15, 1996
Days to Decision 85 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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