Skip to content

SmartMAR

by GE Healthcare Japan Corporation

Ref 5869274

SmartMAR (5869274) is a CT system application software (EU MDR Class IIa; FDA Class II; FDA product code JAK, System, x-ray, tomography, computed) made by GE Healthcare Japan Corporation, registered in EUDAMED on 2 Nov 2023 (Basic UDI-DI 8406821BUG00156HC), cleared under FDA 510(k) K132410 on 17 Jan 2014 and listed in FDA GUDID since 25 Aug 2021 (UDI-DI 00195278303219), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132410

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00156HC Basic UDI-DI 00195278303219UDI-DIDate2 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278303219 UDI-DI Date25 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132410 Date17 Jan 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00156HC registered 2 Nov 2023 Active
  • FDA 510(k) K132410 decided 17 Jan 2014 Active
  • FDA GUDID UDI-DI 00195278303219 listed 25 Aug 2021 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2581-2018 FDA Class II initiated 24 May 2018

    Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

    • Terminated Z-2184-2017 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

5 dated events

  1. Cleared FDA 510(k) K132410
  2. Recall initiated FDA recalls Z-2184-2017
  3. Recall initiated FDA recalls Z-2581-2018
  4. Listed FDA GUDID 00195278303219
  5. Registered EUDAMED 8406821BUG00156HC

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SmartMAR EUDAMED
Mar GUDID
Generic name
CT system application software
Model / Ref / Catalog
5869274, 1.1
Primary DI / UDI-DI
00195278303219
Basic UDI-DI
8406821BUG00156HC
510(k) Number
FDA product code
JAK
EMDN code
Z11030692 Computed tomographs (CT) - medical device software
GMDN term
CT system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1750
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
5869274
GUDID
1.1
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
JP-MF-000009291
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE.

Other devices from GE Healthcare Japan Corporation

See all devices from GE Healthcare Japan Corporation →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)