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FCT iStream

by FUJIFILM Corporation

Ref FCT iStream

FCT iStream is a device classified as Class IIb in the EU and Class II in the US made by Fujifilm Corporation, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 45735962010100000000001Y8), cleared under FDA 510(k) K253836 on 4 Sep 2026 (1 earlier submission) and listed in FDA GUDID since 12 Jul 2024 (UDI-DI 04573596204382), active as of 7 Nov 2026.

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 found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253836

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number45735962010100000000001Y8 Basic UDI-DI 04573596204382UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK253836 Date4 Sep 2026DecidedStatusActive
United StatesGUDID listing GUDID Number04573596204382 UDI-DI Date12 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 45735962010100000000001Y8 registered 21 Oct 2026 Active
  • FDA 510(k) K253836 decided 4 Sep 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04573596204382 listed 12 Jul 2024 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K233583
  2. Listed FDA GUDID 04573596204382
  3. Cleared FDA 510(k) K253836
  4. Registered EUDAMED 45735962010100000000001Y8

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  • Withdrawn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

Generic name
Full-body CT system
Model / Ref / Catalog
FCT iStream
Primary DI / UDI-DI
04573596204382
Basic UDI-DI
45735962010100000000001Y8
510(k) Number
FDA product code
JAK
EMDN code
Z11030606 Computed tomographs - 128 layers or more but less than 256 layers
GMDN term
Full-body CT system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
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.

Manufacturer details

EUDAMED SRN
JP-MF-000010401
Authorised representative
FUJIFILM Healthcare Europe GmbH DE-AR-000040920

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)