Innova Igs 6 001: CE/MDD Class IIb, GE Medical Systems, LLC

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00840682124614 Basic UDI-DI 00840682124614UDI-DI	Date3 Sep 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK181403	Date2 Nov 2018Decided	StatusActive
United States	GUDID listing GUDID	Number00840682124614 UDI-DI	Date11 Feb 2018Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI B-00840682124614 — open Devices and search for it
AccessGUDID record UDI-DI 00840682124614
FDA 510(k) database 510(k) number K181403

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-00840682124614 registered 3 Sep 2026 Active
FDA 510(k) K181403 decided 2 Nov 2018 Active
FDA GUDID UDI-DI 00840682124614 listed 11 Feb 2018 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

9 dated events

11 Feb 2018 Listed FDA GUDID 00840682124614
2 Nov 2018 Cleared FDA 510(k) K181403
15 Mar 2019 Recall initiated FDA recalls Z-1201-2019
19 Apr 2021 Recall initiated FDA recalls Z-1864-2021
18 Mar 2024 Recall initiated FDA recalls Z-1777-2024
18 Mar 2024 Recall initiated FDA recalls Z-1783-2024
18 Mar 2024 Recall initiated FDA recalls Z-1778-2024
18 Mar 2024 Recall initiated FDA recalls Z-1782-2024
3 Sep 2026 Registered EUDAMED B-00840682124614

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Innova IGS 6 EUDAMED
Innova GUDID
Generic name: Stationary angiographic x-ray system, digital
Model / reference: Innova IGS 6 EUDAMED
5771387 EUDAMED
IGS 6 001 GUDID

Primary DI / UDI-DI: 00840682124614
Basic UDI-DI: B-00840682124614
510(k) Number: K181403
FDA product code: OWB, JAA, IZI
EMDN code: Z11030103 Biplanar angiography systems
GMDN term: Stationary angiographic x-ray system, digital

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 892.1650, 892.1600
EU registration type: Legacy device (under a directive)
EU market of registration: France
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED Innova IGS 6 5771387	GUDID IGS 6 001
Device class	EUDAMED Class IIb	GUDID Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.