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Optima IGS Mega

by GE Hualun Medical Systems Co., Ltd

Optima IGS Mega is a Class II device made by GE Hualun Medical Systems Co., Ltd, cleared under FDA 510(k) K181403 on 2 Nov 2018 and listed in FDA GUDID since 20 Oct 2022 (UDI-DI 00195278524911), active as of 23 Oct 2026. 6 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

510(k) K181403

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00195278524911 UDI-DI Date20 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181403 Date2 Nov 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181403 decided 2 Nov 2018 Active
  • FDA GUDID UDI-DI 00195278524911 listed 20 Oct 2022 Listed

Recalls

6 recalls · 5 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1777-2024 FDA Class II initiated 18 Mar 2024
    • Ongoing Z-1783-2024 FDA Class II initiated 18 Mar 2024
    • Ongoing Z-1778-2024 FDA Class II initiated 18 Mar 2024
    • Ongoing Z-1782-2024 FDA Class II initiated 18 Mar 2024

    GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

    • Ongoing Z-1201-2019 FDA Class II initiated 15 Mar 2019

    There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

    • Terminated Z-1864-2021 FDA Class II initiated 19 Apr 2021

    The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.

Timeline

8 dated events

  1. Cleared FDA 510(k) K181403
  2. Recall initiated FDA recalls Z-1201-2019
  3. Recall initiated FDA recalls Z-1864-2021
  4. Listed FDA GUDID 00195278524911
  5. Recall initiated FDA recalls Z-1777-2024
  6. Recall initiated FDA recalls Z-1783-2024
  7. Recall initiated FDA recalls Z-1778-2024
  8. Recall initiated FDA recalls Z-1782-2024

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optima
Generic name
Stationary angiographic x-ray system, digital
Model / reference
IGS Mega
Primary DI / UDI-DI
00195278524911
510(k) Number
FDA product code
IZI, OWB, JAA
GMDN term
Stationary angiographic x-ray system, digital
Device class
Class II
Regulation number
892.1600, 892.1650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary angiographic x-ray system, digital

Cleared under the same submission (K181403)

Similar devices in this category

Other devices filed under Stationary angiographic x-ray system, digital.

Other devices from GE Hualun Medical Systems Co., Ltd

See all devices from GE Hualun Medical Systems Co., Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)