Ust-5413

by Fujifilm Corporation

Ust-5413 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K122341 on 26 Sep 2012 (3 earlier submissions) and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 04573596212769), 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

+3 more

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	Number04573596212769 UDI-DI	Date15 Jul 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK122341	Date26 Sep 2012Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK111227	Date13 May 2011Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK093488	Date20 Nov 2009Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK080176	Date29 Feb 2008Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04573596212769
FDA 510(k) database 510(k) number K122341
FDA 510(k) database 510(k) number K111227
FDA 510(k) database 510(k) number K093488
FDA 510(k) database 510(k) number K080176

Across registries

2 registries list this device

FDA 510(k) K122341 decided 26 Sep 2012 Active· +3 more in the status table
FDA GUDID UDI-DI 04573596212769 listed 15 Jul 2021 Listed

Timeline

5 dated events

29 Feb 2008 Cleared FDA 510(k) K080176
20 Nov 2009 Cleared FDA 510(k) K093488
13 May 2011 Cleared FDA 510(k) K111227
26 Sep 2012 Cleared FDA 510(k) K122341
15 Jul 2021 Listed FDA GUDID 04573596212769

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Extracorporeal ultrasound imaging transducer, hand-held
Model / reference: UST-5413

Primary DI / UDI-DI: 04573596212769
FDA product code: IYO, IYN, ITX
GMDN term: Extracorporeal ultrasound imaging transducer, hand-held

Device class: Class II
Regulation number: 892.1560, 892.1550, 892.1570
GUDID distribution status: In Commercial Distribution

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Other devices filed under Extracorporeal ultrasound imaging transducer, hand-held.

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)