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IMRISeye P122506

by IMRIS Imaging, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850085914002 UDI-DIDate7 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
IMRISeye
Generic Name
Radiological general body-part positioner
Model / Reference
P122506
Primary DI / UDI-DI
00850085914002
FDA Product Code
FTY
GMDN Term
Radiological general body-part positioner
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Other devices from IMRIS Imaging, Inc.

See all devices from IMRIS Imaging, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No