510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K100691Substantially Equivalent

Omni V Sbrt Positioning System, Model Rt-4500

Bionix Development Corp., Toledo OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100691 is the FDA 510(k) clearance record for OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500, a class II device, cleared for Bionix Development Corp. on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 13 510(k) clearances for Bionix Development Corp., from to . As of , FDA records show no recalls naming K100691.

Clearance record

Decision date
Received
(62 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Bionix Development Corp. 5154 Enterprise Blvd., Toledo OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYE

Trailing 12 months
16 clearances under product code IYE in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code IYE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20260
March 20261
April 20262
May 20261
June 20262
July 20260
August 20263
September 20261
October 20260