iMRI 3T S

FDA UDI

Class II (US FDA UDI)

by IMRIS Imaging, Inc.

Identity

Trade Name: iMRI 3T S FDA UDI
Generic Name: Full-body MRI system, superconducting magnet FDA UDI
Device Name: IMRIS SSK OR-DR Full Body Imaging, 116119-000 FDA UDI
Model / Reference: OR-DR 116119-000 FDA UDI
Description: IMRIS SSK OR-DR Full Body Imaging, 116119-000 FDA UDI

Identifiers

Primary DI / UDI-DI: 00857534006066 FDA UDI
510(k) Number: K133692 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: Full-body MRI system, superconducting magnet FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Full-body MRI system, superconducting magnet

iMRI 3T S by IMRIS Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Full-body MRI system, superconducting magnet.

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1.5T HDxt Upgrade Kit — GE MEDICAL SYSTEMS, INC. · Class IIa
Flex Large 8 Coil Set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
Flex small 4 MR coil set 3T — Siemens Healthcare · Class II
Head/Neck 20 MR Coil 1.5T — Siemens Healthcare · Class II

Cleared under the same submission

K133692 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: IMRIS Imaging, Inc.

Sources (1)

FDA UDI 657f97ad-2153-4e77-9189-4d7e8f0583fc 34 fields · synced May 30, 2026