Support cushion comfort Breast BI 7

FDA UDI

Class II (US FDA UDI)

by NORAS MRI products GmbH

Identity

Trade Name: Support cushion comfort Breast BI 7 FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: The support cushion serves as a comfortable rest on the coil housing of the Breast BI 7. The use of the support cushion ensures that the patient can lie comfortably on the coil even for several minutes, so that movement artefacts can be minimised. FDA UDI
Model / Reference: 01 FDA UDI
Description: The support cushion serves as a comfortable rest on the coil housing of the Breast BI 7. The use of the support cushion ensures that the patient can lie comfortably on the coil even for several minutes, so that movement artefacts can be minimised. FDA UDI

Identifiers

Catalog Number: 120177 FDA UDI
Primary DI / UDI-DI: 04251269207013 FDA UDI
510(k) Number: K162651 FDA UDI
K180123 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: MRI system coil, radio-frequency

Support cushion comfort Breast BI 7 by NORAS MRI products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: NORAS MRI products GmbH

Sources (1)

FDA UDI 54f21627-41fa-41b2-9462-39db9a3ed38c 36 fields · synced Jun 8, 2026