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GE Delta Software Option for MRI

by GE Medical Systems

510(k) K031927

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 NumberK031927 Date2 Jul 2003ClearedStatusActive

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  • Withdrawn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
LNH
Device class
Class II
Regulation
21 CFR Part 892.1000
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 25 Sep 2026

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

The GE Delta Software Option for MRI is an analytical software tool that provides reproducible tools for the review and reporting of medical images. It can import medical images from a magnetic resonance (MR) system and display them in a viewing area on a computer screen.

This device is classified as a System, Nuclear Magnetic Resonance Imaging under product code LNH and received FDA 510(k) clearance (K031927) on July 2, 2003. It is a Class II device subject to special controls and was submitted by GE Medical Systems in Waukesha, Wisconsin.

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