1.5T 16ch Breast Coil
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
by NeoCoil, LLC
Identity
- Trade Name
- 1.5T 16ch Breast Coil EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 16ch Breast Coil EUDAMEDThe NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 1.5T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The 1.5T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads. FDA UDI
- Model / Reference
- 16ch Breast Coil EUDAMEDM7006PH EUDAMED89 FDA UDI
- Description
- The NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 1.5T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The 1.5T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads. FDA UDI
Identifiers
- Catalog Number
- M7006PH FDA UDI
- Primary DI / UDI-DI
- 00856181003893 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932387S EUDAMED
- 510(k) Number
- K182958 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS 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
- Netherlands 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
Yes
Category: MRI system coil, radio-frequency
1.5T 16ch Breast Coil by Neocoil, Llc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222407 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K182958 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850028932387S | Class I | Active |
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Manufacturer
- Manufacturer
- NeoCoil, LLC
- EUDAMED SRN
- US-MF-000027128
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 57db4efe-e301-4f90-9cd7-5ae46192c095 85 fields · synced Jun 19, 2026
- FDA UDI f3423694-c27e-4c10-9d1d-3a2d65a1001b 35 fields · synced May 30, 2026
- FDA 510(k) K222407 1 fields · synced May 18, 2026