uMR

FDA UDI

Class II (US FDA UDI)

by Uih Technologies, Llc

Identity

Trade Name: uMR FDA UDI
Generic Name: Full-body MRI system, superconducting magnet FDA UDI
Device Name: The uMR 570 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan. FDA UDI
Model / Reference: uMR 570 FDA UDI
Description: The uMR 570 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810030350057 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

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Full-body MRI system, superconducting magnet

uMR by Uih Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Uih Technologies, Llc

Sources (1)

FDA UDI 1c35877d-753c-405c-9562-df043d3bfcda 33 fields · synced Jun 6, 2026