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i-Dixel

by J.morita Mfg.corp. 24 variants

i-Dixel is a Class II device made by J.morita Mfg.corp., cleared under FDA 510(k) K073704 on 21 Feb 2008, registered in EUDAMED and listed in FDA GUDID since 12 Feb 2017 (UDI-DI 04548213026845), active as of 23 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 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04548213026845 UDI-DI Date12 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK073704 Date21 Feb 2008DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K073704 decided 21 Feb 2008 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 04548213026845 listed 12 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K073704
  2. Listed FDA GUDID 04548213026845

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  • Withdrawn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
Basic x-ray clinical assessment support software
Model / reference
i-Dixel
Primary DI / UDI-DI
04548213026845
510(k) Number
FDA product code
LLZ
GMDN term
Basic x-ray clinical assessment support software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic diagnostic x-ray system application software

Cleared under the same submission (K073704)

and 8 more cleared under K073704

Similar devices in this category

Other devices filed under Basic diagnostic x-ray system application software.

Other devices from J.morita Mfg.corp.

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

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)