InSitu Coil

FDA UDI

Class II (US FDA UDI)

by IMRIS Imaging, Inc.

Identity

Trade Name: InSitu Coil FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: InSitu Coil, Open, 3T Large, 120019-000 FDA UDI
Model / Reference: InSitu Coil, Open, 3T Large FDA UDI
Description: InSitu Coil, Open, 3T Large, 120019-000 FDA UDI

Identifiers

Catalog Number: 120019-000 FDA UDI
Primary DI / UDI-DI: 00857534006554 FDA UDI
510(k) Number: K123091 FDA UDI
FDA Product Code: MOS FDA UDI
GMDN Term: MRI system coil, radio-frequency 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: MRI system coil, radio-frequency

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

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Cleared under the same submission

K123091 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 b3ce52cd-1ebc-43e2-a181-9dd37fd62654 35 fields · synced May 30, 2026