Cleared Traditional

VERIDOSE DIODES

K964785 · Victoreen, Inc. · Radiology
Jun 1997
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K964785 is an FDA 510(k) clearance for the VERIDOSE DIODES, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Victoreen, Inc. (Solon, US). The FDA issued a Cleared decision on June 13, 1997, 196 days after receiving the submission on November 29, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K964785 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1996
Decision Date June 13, 1997
Days to Decision 196 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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