Nyquist.IQ

GUDID 00853901007032

Digital Medical Image Processor

OMEGA MEDICAL IMAGING, LLC

X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose

• Primary Device ID: 00853901007032
• NIH Device Record Key: 98c37fdf-40b3-4782-95ae-ed0fac72a5bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nyquist.IQ
• Version Model Number: IPS-100
• Company DUNS: 622534493
• Company Name: OMEGA MEDICAL IMAGING, LLC
• Device Count: 1
• DM Exempt: true
• 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	00853901007032 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2022-03-25
• Device Publish Date: 2022-03-17

Devices Manufactured by OMEGA MEDICAL IMAGING, LLC

• 00853901007032 - Nyquist.IQ: 2022-03-25Digital Medical Image Processor
• 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: 2020-01-13 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