Nmct 870CZT: CE/MDD Class IIb

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00840682140843 Basic UDI-DI 00840682140843UDI-DI	Date15 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00840682140843 UDI-DI	Date21 May 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK153402	Date21 Jan 2016Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-00840682140843 — open Devices and search for it
AccessGUDID record UDI-DI 00840682140843
FDA 510(k) database 510(k) number K153402

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-00840682140843 registered 15 Oct 2026 Active
FDA 510(k) K153402 decided 21 Jan 2016 Active
FDA GUDID UDI-DI 00840682140843 listed 21 May 2018 Listed

Recalls

6 recalls · 1 ongoing · FDA

- Ongoing Z-1057-2023 FDA Class I initiated 19 Dec 2022
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
- Terminated Z-0855-2021 FDA Class II initiated 10 Dec 2020
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
- Terminated Z-2993-2020 FDA Class II initiated 14 Aug 2020
Rotor bearing screws were found loose on detector.
2 recalls, same reason
- Terminated Z-1258-2019 FDA Class II initiated 20 Mar 2019
- Terminated Z-1264-2019 FDA Class II initiated 20 Mar 2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- Terminated Z-2195-2017 FDA Class II initiated 19 May 2017
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Timeline

9 dated events

21 Jan 2016 Cleared FDA 510(k) K153402
19 May 2017 Recall initiated FDA recalls Z-2195-2017
21 May 2018 Listed FDA GUDID 00840682140843
20 Mar 2019 Recall initiated FDA recalls Z-1258-2019
20 Mar 2019 Recall initiated FDA recalls Z-1264-2019
14 Aug 2020 Recall initiated FDA recalls Z-2993-2020
10 Dec 2020 Recall initiated FDA recalls Z-0855-2021
19 Dec 2022 Recall initiated FDA recalls Z-1057-2023
15 Oct 2026 Registered EUDAMED B-00840682140843

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: Nm/CT 870 Czt EUDAMED
Nmct GUDID
Generic name: Full-body CT system
Model / reference: NM/CT 870 CZT EUDAMED
H3906CV EUDAMED
H3906EL EUDAMED
870CZT GUDID

Primary DI / UDI-DI: 00840682140843
Basic UDI-DI: B-00840682140843
510(k) Number: K153402
FDA product code: JAK, KPS
EMDN code: Z11020201 CT/gamma camera systems
GMDN term: Full-body CT system

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 892.1750, 892.1200
System or procedure pack: System which is a device in itself
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 NM/CT 870 CZT H3906CV, H3906EL	GUDID 870CZT
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.