Cleared Traditional

OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500

K100691 · Bionix Development Corp. · Radiology
May 2010
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K100691 is an FDA 510(k) clearance for the OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on May 11, 2010, 62 days after receiving the submission on March 10, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K100691 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2010
Decision Date May 11, 2010
Days to Decision 62 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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