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ORT400 Table 119900-000

by IMRIS Imaging, Inc.

ORT400 Table 119900-000 is a Class I device made by IMRIS Imaging, Inc., listed in FDA GUDID since 4 Oct 2024 (UDI-DI 00857534006691), 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 Number00857534006691 UDI-DI Date4 Oct 2024ListedStatusListed 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  • Withdrawn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
ORT400 Table
Generic name
MRI system table, powered
Model / reference
119900-000
Primary DI / UDI-DI
00857534006691
FDA product code
GDC, KXJ
GMDN term
MRI system table, powered
Device class
Class I
Regulation number
878.4960, 892.1980
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Similar devices

Other devices filed under FDA product code GDC (Table, Operating-Room, Electrical).

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)