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Magnetic Resonance Diagnostic Accessory

FDA 510(k)

Class II (US FDA 510(k))

510(k) K953595

by Ge Medical Systems

Identifiers

510(k) Number
K953595 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 Magnetic Resonance, Specialty Coil, designed to enhance MRI signal reception and image quality for diagnostic purposes. Specialty coils are tailored for specific anatomical regions or imaging techniques, improving resolution and contrast in magnetic resonance imaging systems.

The accessory is intended for use in MRI-equipped radiology settings and is supplied as a reusable component. It requires compatibility with GE Medical Systems MRI platforms and adheres to FDA 510(k) clearance (K953595) under the Radiology advisory committee. No sterility or single-use specifications are noted, and MRI safety compliance is implied by its classification as a diagnostic accessory.

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: MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K944979) — FDA 510 (k ..., K944112 FDA 510(k) - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY, Magnetic Resonance Imaging | GE HealthCare Service Shop USA, Magnetic Resonance Imaging (MRI) - GE Healthcare

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ge Medical Systems

Sources (1)

  • FDA 510(k) K953595 24 fields · synced Oct 6, 2026