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Nyquist.IQ IPS-100

by Omega Medical Imaging, LLC

Nyquist.IQ IPS-100 is a X-ray system computer (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Omega Medical Imaging, LLC, listed in FDA GUDID since 17 Mar 2022 (UDI-DI 00853901007032), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00853901007032 UDI-DI Date17 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Nyquist.IQ
Generic name
X-ray system computer, diagnostic, general-purpose
Model / reference
IPS-100
Primary DI / UDI-DI
00853901007032
FDA product code
LLZ
GMDN term
X-ray system computer, diagnostic, general-purpose
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

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

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Omega Medical Imaging, LLC

See all devices from Omega Medical Imaging, LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)