Identity
- Trade Name
- Breast BI 7 MR Coil Set 3T FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician. FDA UDI
- Model / Reference
- 10 FDA UDI
- Description
- The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician. FDA UDI
Identifiers
- Catalog Number
- 118890 FDA UDI
- Primary DI / UDI-DI
- 04251269207389 FDA UDI
- 510(k) Number
- K220144 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
Category: MRI system coil, radio-frequency
Breast BI 7 MR Coil Set 3T 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
K220144 also covers:
- Breast BI 7 MR Coil Set 1.5T — NORAS MRI products GmbH
- Breast BI 7 MR Coil Set 1.5T — NORAS MRI products GmbH
- Breast BI 7 MR Coil Set 3T — NORAS MRI products GmbH
- Breast BI Coil — NORAS MRI products GmbH
- Filling cushion Breast BI — NORAS MRI products GmbH
- Head rest Breast BI — NORAS MRI products GmbH
- Hip support cushion Breast BI — NORAS MRI products GmbH
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 d681724b-3df1-4eb3-89f6-4cbc3e1f98e8 36 fields · synced May 30, 2026