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Magnetic Resonance Diagnostic System

by GE Medical Systems, Inc.

510(k) K972296

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972296 Date15 Sep 1997ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MOS
Device class
Class II
Regulation
21 CFR Part 892.1000
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This is a Magnetic Resonance Diagnostic System, a medical device used for diagnostic imaging in radiology. It is classified as a Class II device under FDA regulation number 892.1000 and has received FDA 510(k) clearance (K972296) as substantially equivalent to a predicate device.

The system is manufactured by GE Medical Systems, Inc. and is intended for use in radiology settings. It is supplied as a non-sterile, reusable system for diagnostic imaging procedures. No specific sterility, single-use status, MRI safety details, sizes, or storage conditions are provided in the data.

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