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i-Dixel

by J. Morita Mfg. Corp.

Ref i-Dixel

i-Dixel is a medical device (EU MDR Class I; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological; EMDN category computed tomographs (ct) - software accessories) made by J.morita Mfg.corp., registered in EUDAMED on 21 Apr 2026 (Basic UDI-DI 4548213000B0022DV), cleared under FDA 510(k) K073704 on 21 Feb 2008 and listed in FDA GUDID since 2 Feb 2018 (UDI-DI 04548213030804), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K073704

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4548213000B0022DV Basic UDI-DI 04548213030804UDI-DIDate21 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04548213030804 UDI-DI Date2 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK073704 Date21 Feb 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4548213000B0022DV registered 21 Apr 2026 Active
  • FDA 510(k) K073704 decided 21 Feb 2008 Active
  • FDA GUDID UDI-DI 04548213030804 listed 2 Feb 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K073704
  2. Listed FDA GUDID 04548213030804
  3. Registered EUDAMED 4548213000B0022DV

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  • Withdrawn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
Stationary panoramic/tomographic dental x-ray system, digital
Model / reference
i-Dixel
Primary DI / UDI-DI
04548213030804
Basic UDI-DI
4548213000B0022DV
510(k) Number
FDA product code
LLZ
EMDN code
Z11030682 Computed tomographs (CT) - software accessories
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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-000023000
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Related devices

Category: Full-body CT system

Similar devices in this category

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

Other devices from J.morita Mfg.corp.

See all devices from J.morita Mfg.corp. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (22, all answered No)