Nyquist.IQ

GUDID 00853901007032

Digital Medical Image Processor

OMEGA MEDICAL IMAGING, LLC

X-ray system computer, diagnostic, general-purpose
Primary Device ID00853901007032
NIH Device Record Key98c37fdf-40b3-4782-95ae-ed0fac72a5bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNyquist.IQ
Version Model NumberIPS-100
Company DUNS622534493
Company NameOMEGA MEDICAL IMAGING, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853901007032 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-25
Device Publish Date2022-03-17

Devices Manufactured by OMEGA MEDICAL IMAGING, LLC

00853901007032 - Nyquist.IQ2022-03-25Digital Medical Image Processor
00853901007032 - Nyquist.IQ2022-03-25 Digital Medical Image Processor
00853901007025 - Omega Medical Imaging, LLC2022-01-26 Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and
00853901007001 - Omega Medical Imaging2020-01-13 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, LLC2019-08-27 CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray

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