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Neuro II-SE 105000-00X

by IMRIS Imaging, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857534006929 UDI-DIDate20 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

2 recalls · FDA

    • Terminated Z-1098-2016 FDA Class II initiated 10 Feb 2016

    Emergency helium venting lines (i.e. quench lines) may not have been properly installed.

    • Terminated Z-0428-2013 FDA Class II initiated 19 Oct 2012

    IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.

Specification

GUDID

Trade Name
Neuro II-SE
Generic Name
Full-body MRI system, superconducting magnet
Model / Reference
105000-00X
Primary DI / UDI-DI
00857534006929
510(k) Number
FDA Product Code
LNH
GMDN Term
Full-body MRI system, superconducting magnet
Device Class
Class II
Regulation Number
892.1000
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
  • Serial Number
  • Manufacturing Date

Other properties (11)

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