3.0.t Signa Vh/I (t/R) Body Imaging Coil
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K003613 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)
This device is a Coil, Magnetic Resonance, Specialty, as defined in the device data. It is designed for use in magnetic resonance imaging (MRI) systems to receive radiofrequency signals from the body during imaging procedures.
It is supplied as a reusable, non-sterile accessory for MRI scanners. The device received FDA 510(k) clearance (K003613) on April 3, 2001, and is classified as a Class II medical device under regulation 892.1000 with product code MOS. It is intended for use in radiology settings and does not have any stated sterility, single-use, or MRI safety conditions beyond its function as an RF coil.
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: K003613 FDA 510(k) - 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL, 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL 510(k) K003613 - fda.report, 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL (K003613) — FDA 510(k ..., GE SIGNA - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003613 | Class II | Active |
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Manufacturer
- Manufacturer
- Ge Medical Systems
Sources (1)
- FDA 510(k) K003613 24 fields · synced Oct 6, 2026