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 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04548213024728), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04548213024728 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK073704	Date21 Feb 2008Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04548213024728
FDA 510(k) database 510(k) number K073704

Across registries

2 registries list this device

FDA 510(k) K073704 decided 21 Feb 2008 Active
FDA GUDID UDI-DI 04548213024728 listed 23 Sep 2016 Listed

Timeline

2 dated events

21 Feb 2008 Cleared FDA 510(k) K073704
23 Sep 2016 Listed FDA GUDID 04548213024728

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Basic x-ray clinical assessment support software
Model / reference: i-Dixel

Primary DI / UDI-DI: 04548213024728
510(k) Number: K073704
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

Similar devices in this category

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

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Properties

Prescription use
Serial number

Other properties (13, all answered No)