1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181948 FDA 510(k)
- FDA Product Code
- MOS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a Magnetic Resonance, Specialty Coil designed for diagnostic imaging of the breast. It is a high-channel receiver coil configured for use at 1.5 Tesla and 3.0 Tesla magnetic resonance imaging systems, enabling high-resolution imaging of breast tissue for clinical evaluation.
Supplied as a reusable device, the coils are intended for use in MRI-compatible environments and must comply with MRI safety standards. They are not sterile and require cleaning and maintenance between uses. Authorised under FDA 510K and MDR, the coils are classified as Class II devices and are regulated under the respective regulatory frameworks for magnetic resonance imaging accessories.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181948 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rapid Biomedical Gmbh
Sources (2)
- FDA 510(k) K181948 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026