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Ge Discovery Igs Angiographic, Fluoroscopic X-Ray System

by GE Medical Systems SCS 510(k)

Active United States

510(k) K113403

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113403 Date14 Feb 2012ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

4 recalls · FDA

    • Terminated Z-2386-2018 FDA Class II initiated 29 Mar 2018

    The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.

    • Terminated Z-1706-2016 FDA Class II initiated 15 Apr 2016

    Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.

    • Terminated Z-0966-2015 FDA Class II initiated 10 Dec 2014

    Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.

    • Terminated Z-2253-2013 FDA Class II initiated 19 Jun 2013

    GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system ma

Specification

510(k)

510(k) Number
FDA Product Code
OWB
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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