3.0T 16Ch Diagnostic Breast Coil positioning parts set
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 3.0T 16Ch Diagnostic Breast Coil EUDAMEDFDA UDI3.0T 16Ch Diagnostic Breast Coil positioning parts set FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Breast Coil EUDAMED3.0T 16Ch Diagnostic Breast Coil positioning parts set FDA UDI3.0T 16Ch Diagnostic Breast Coil (FRU) FDA UDI
- Model / Reference
- 01630 EUDAMEDZUB-01858 FDA UDIP-H16LE-030-01630 FDA UDI
- Description
- 3.0T 16Ch Diagnostic Breast Coil positioning parts set FDA UDI3.0T 16Ch Diagnostic Breast Coil (FRU) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260487680102 EUDAMEDFDA UDI04260487680201 FDA UDI
- Basic UDI-DI
- 426048768FAMBreast_IBJ EUDAMED
- Direct Marketing DI
- 04260487680102 EUDAMED
- 510(k) Number
- K181948 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: MRI system coil, radio-frequency
3.0T 16Ch Diagnostic Breast Coil positioning parts set by RAPID Biomedical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as MRI system coil, radio-frequency.
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Cleared under the same submission
K181948 also covers:
- 1.5T 16Ch Diagnostic Breast Coil — RAPID Biomedical GmbH
- 1.5T 16Ch Diagnostic Breast Coil positioning parts set — RAPID Biomedical GmbH
- 16Ch Diagnostic Breast Coil — RAPID Biomedical GmbH
- 16Ch Diagnostic Breast Coil — RAPID Biomedical GmbH
- 16Ch Diagnostic Breast Coil Cushion Set — RAPID Biomedical GmbH
- 16Ch Diagnostic Breast Coil Head Rest Framework — RAPID Biomedical GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RAPID Biomedical GmbH
Sources (3)
- FDA UDI aa113db2-1673-40db-b260-344577c07334 35 fields · synced Jul 9, 2026
- FDA UDI b437c18d-3e66-49d5-bee3-28402cae9b93 35 fields · synced May 30, 2026
- EUDAMED 4f118674-a664-4cbf-b8a9-e76dbd736152 61 fields · synced Jul 9, 2026