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iRay CRUX FR10

by iRay Imaging Technology (Haining) Limited 2 variants

iRay CRUX FR10 is a medical device (FDA Class II; FDA product code IZX, Collimator, Manual, Radiographic) made by iRay Imaging Technology (Haining) Limited, listed in FDA GUDID since 2 Jul 2025 (UDI-DI 06975501940459), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06975501940459 UDI-DI Date2 Jul 2025ListedStatusListed 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  • Withdrawn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
iRay
Generic name
Manual-aperture-control diagnostic x-ray system collimator, non-motorized
Model / reference
CRUX FR10
Primary DI / UDI-DI
06975501940459
FDA product code
IZX
GMDN term
Manual-aperture-control diagnostic x-ray system collimator, non-motorized
Device class
Class II
Regulation number
892.1610
GUDID distribution status
In Commercial Distribution

Related devices

Category: Manual-aperture-control diagnostic x-ray system collimator, non-motorized

Other devices from iRay Imaging Technology (Haining) Limited

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)