Cleared Traditional

K100691 - OMNI V SBRT POSITIONING SYSTEM

K100691 is the FDA 510(k) clearance for OMNI V SBRT POSITIONING SYSTEM by Bionix Development Corp.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

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

K100691 is an FDA 510(k) clearance for the OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on May 11, 2010 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bionix Development Corp. devices

Submission Details

510(k) Number K100691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 107d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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