Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500

K-Number: K100691 · 2010-05-11

ApplicantBionix Development Corp.
Decision Date2010-05-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2010-05-11 under 510(k) number K100691. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500?

OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 is a medical device that received FDA 510(k) clearance on 2010-05-11. The listed applicant is Bionix Development Corp.. The 510(k) number is K100691.

When did OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 receive FDA 510(k) clearance?

OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 received FDA 510(k) clearance on 2010-05-11, under 510(k) number K100691.

Who is the listed applicant for OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500?

The FDA 510(k) record lists Bionix Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500?

The FDA product code for OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 is IYE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bionix Development Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153270TruGuard Custom Tongue and Jaw PositionerK123411LITTLE ANGELS SWADDLING BLANKETK120335EMBRACE THERMOPLASTICK100264T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060K050701THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010K040773PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM

View all 12 devices →

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑