Omega Equipment

Omega Equipment

Please call (909) 595-5985 for full information and brochures.

Click Here for brochure: OMEGA Brochure.pdf

Omega offers it's Dedicated Electrophysiology Fluoro Systems in both single plane and bi-plane configurations. All systems can be configured with Fluoro Only, Fluoro-Fluoro Loop, or Fluoro - Cine modes of operation. additionally, Bi-plane systems can be configured with different Frontal and Lateral plane modes, such as Fluoro-Cine on the Frontal plane, and Fluoro Only on the Lateral plane.

Omega Medical Imaging is committed to delivering high quality, state of the art, fluoroscopic x-ray imaging systems.

Customer satisfaction is our goal. It is met through the maintenance and improvement of effectiveness of our quality system.

Omega is a medical device manufacturer and operates its business in accordance with the FDA Quality Systems Regulations and is operated in compliance with ISO 13485:2003.

Omega’s management is committed to this policy and all Omega team members are responsible for the implementation of this policy.

Compliance

Omega Medical Imaging, Inc. is a medical device manufacture and as such operates its business in accordance with the FDA Quality Standards Regulations.

All Omega Medical Imaging, Inc. products comply with the FDA requirements under Code of Federal Regulation, Section 21, parts 1020.30, 1020.31, and 1020.32, Medical Device Directive 93/42/EEC, and the Canadian Medical Device Regulations (CMDR).

Omega Medical Imaging, Inc. products have been certified to UL 60601-1:2003, CAN/CSA C22.2 No. 601.1-M90 by Intertek ETL SEMKO.

All Omega Medical Imaging, Inc. products comply with all relevant IEC 60601 Particular and Collateral Standards, including the following:

IEC 60601-1-2
IEC 60601-1-3
IEC 60601-2-7
IEC 60601-2-28
IEC 60601-2-32

The Technical File containing evidence of this Compliance is reviewed and is continuously surveyed by RWTUV. RWTUV grants Omega Medical Imaging, Inc. permission to attach the RWTUV registered CE Mark on all Omega Medical Imaging, Inc. products, manuals, and advertising literature.