ORT400 Table

FDA UDI

Class I (US FDA UDI)

by IMRIS Imaging, Inc.

Identity

Trade Name: ORT400 Table FDA UDI
Generic Name: MRI system table, powered FDA UDI
Device Name: ORT400 Table FDA UDI
Model / Reference: 119900-000 FDA UDI
Description: ORT400 Table FDA UDI

Identifiers

Primary DI / UDI-DI: 00857534006691 FDA UDI
FDA Product Code: GDC FDA UDI
KXJ FDA UDI
GMDN Term: MRI system table, powered FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4960 FDA UDI
892.1980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Basic diagnostic x-ray system table, powered MRI system table, powered

ORT400 Table by IMRIS Imaging, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI system table, powered.

AADCO — AADCO MEDICAL, INC. · Class II
AADCO — AADCO MEDICAL, INC. · Class II
AADCO — AADCO MEDICAL, INC. · Class II
AADCO — AADCO MEDICAL, INC. · Class II
AADCO — AADCO MEDICAL, INC. · Class II
AADCO — AADCO MEDICAL, INC. · Class II
AADCO — AADCO MEDICAL, INC. · Class II
Headboard Assembly — IMRIS Imaging, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: IMRIS Imaging, Inc.

Sources (1)

FDA UDI e6c029a3-7d3b-49de-b651-576e23a59ff0 33 fields · synced May 30, 2026