OMEGA MEDICAL IMAGING, LLC

Address:3400 St. Johns Parkway, Suite 1020,Sanford,FL,32771,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (2) System, Image Processing, Radiological (LLZ) (1) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (1)

Premarket Exempt

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Omega Medical Imaging - 00853901007001 Catalog Number :

Device Description : CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient tab 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.

Device Class : 2

Duns Number: 622534493

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Omega Medical Imaging, LLC - 00853901007018 Catalog Number :

Device Description : CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consist 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.

Device Class : 2

Duns Number: 622534493

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Omega Medical Imaging, LLC - 00853901007025 Catalog Number :

Device Description : Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and Image Processor.

Device Class : 2

Duns Number: 622534493

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

Nyquist.IQ - 00853901007032 Catalog Number :

Device Description : Digital Medical Image Processor

Device Class : 2

Duns Number: 622534493

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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