Omega Medical Imaging

GUDID 00853901007001

CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.

OMEGA MEDICAL IMAGING, LLC

Stationary angiographic x-ray system, digital

• Primary Device ID: 00853901007001
• NIH Device Record Key: 934517b8-a1aa-45a1-95d6-3d38d2a1f609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omega Medical Imaging
• Version Model Number: CS50
• Company DUNS: 622534493
• Company Name: OMEGA MEDICAL IMAGING, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853901007001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100102

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-13
• Device Publish Date: 2017-05-04

Devices Manufactured by OMEGA MEDICAL IMAGING, LLC

• 00853901007032 - Nyquist.IQ: 2022-03-25 Digital Medical Image Processor
• 00853901007025 - Omega Medical Imaging, LLC: 2022-01-26 Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and
• 00853901007001 - Omega Medical Imaging: 2020-01-13CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.
• 00853901007001 - Omega Medical Imaging: 2020-01-13 CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and I
• 00853901007018 - Omega Medical Imaging, LLC: 2019-08-27 CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray