Data / Medical devices / United States / Uih Technologies, LLC

Uih Technologies, LLC: FDA-registered device maker in Houston, TX, United States, 2 510(k) clearances

Name: Uih Technologies, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Uih Technologies, LLC is registered with the FDA (registration 3014809646) in Houston, TX, United States. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 21, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3014809646
Address: 9380 Kirby Drive, Houston, TX, United States, 77054
Owner or operator: UIH Technologies LLC (10059270)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: April 23, 2020
Registered through: 2027
Brand names listed: uCT 530/550, uCT 760, uCT 760, uCT 780, uCT 780, uDR 380i Pro, uMI 550, uMR 680, uMR Omega

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Coil, Magnetic Resonance, Specialty	MOS	2	Contract manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Contract manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Contract manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Contract manufacturer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Contract manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Contract manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 21, 2026	K253720	uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite	IYN	Substantially Equivalent	Wuhan United Imaging Healthcare Co.,Ltd	accessdata.fda.gov
May 15, 2026	K253716	uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super	IYN	Substantially Equivalent	Wuhan United Imaging Healthcare Co.,Ltd	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 12, 2025	97668	Class II	Ongoing	Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only	Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.	accessdata.fda.gov

Compare with other makers

Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.