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iMRX System

FDA UDI

Class II (US FDA UDI)

by IMRIS Imaging, Inc.

Identity

Trade Name
iMRX System FDA UDI
Generic Name
Full-body MRI system, superconducting magnet FDA UDI
Device Name
iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000 FDA UDI
Model / Reference
ANTERIOR ASSY, 3T 16CH CARDIAC COIL FDA UDI
Description
iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000 FDA UDI

Identifiers

Primary DI / UDI-DI
00857534006141 FDA UDI
510(k) Number
K101813 FDA UDI
FDA Product Code
IZI FDA UDI
LNH FDA UDI
GMDN Term
Full-body MRI system, superconducting magnet FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1600 FDA UDI
892.1000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Full-body MRI system, superconducting magnetStationary angiographic x-ray system, digital

iMRX System by IMRIS Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary angiographic x-ray system, digital.

Cleared under the same submission

K101813 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IMRIS Imaging, Inc.

Sources (1)

  • FDA UDI 949228a7-8f88-4f77-b614-eaf74ffb7546 34 fields · synced May 30, 2026