Neocoil 3.0T 8-CHANNEL Shoulder Array Coil
FDA 510(k)Class II (US FDA 510(k))
by Neocoil
Identifiers
- 510(k) Number
- K071611 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 Neocoil 3.0T 8-Channel Shoulder Array Coil is a multi-element phased array receive-only coil. It is designed for obtaining diagnostic images of the shoulder anatomy within magnetic resonance imaging systems.
This device is compatible with 3.0T MRI scanners and is intended to facilitate patient setup while providing signal-to-noise ratio performance. It has received FDA 510(k) clearance under the regulation number 892.1000.
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. Sources consulted: Shoulder Coils - 1.5T & 3T - NeoCoil, NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL by NEOCOIL | FDA 510 (k) Summary, NEOCOIL, LLC 05 3T 8ch Shoulder Coil - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071611 | Class II | Active |
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Manufacturer
- Manufacturer
- Neocoil
Sources (1)
- FDA 510(k) K071611 24 fields · synced Sep 24, 2026