Omega Medical Imaging, LLC

GUDID 00853901007018

CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray tube, X-ray generator, Flat Panel Detector and Image Processor. The system is configurable with selectable components i.e. tubes, generators, tables, c-arms and flat panel detectors per customer requirements.

OMEGA MEDICAL IMAGING, LLC

Stationary angiographic x-ray system, digital

• Primary Device ID: 00853901007018
• NIH Device Record Key: a8d4cead-dbf6-46dc-9a55-6a5badb935c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omega Medical Imaging, LLC
• Version Model Number: CS-series-FP
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853901007018 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-27
• Device Publish Date: 2019-08-19

On-Brand Devices [Omega Medical Imaging, LLC]

• 00853901007018: CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient
• 00853901007025: Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ra