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Ultraspect Usa, LLC: FDA-registered device maker in Gray, TN, United States, 8 510(k) clearances

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

Ultraspect Usa, LLC is registered with the FDA (registration 3018788582) in Gray, TN, United States. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 19, 2011. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3018788582
Address: 101 Dillion Court, Gray, TN, United States, 37615
Owner or operator: UltraSPECT USA, LLC (10081545)
Roles: Manufacturer
First device listed: April 22, 2021
Registered through: 2026
Brand names listed: UltraSPECT.gate, Xact.Bone, Xact.Cardiac, Xact.Parathyroid, Xpress.Bone, Xpress.Cardiac, Xpress.Cardiac including ACSC, Xpress.PET and more

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer	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
January 19, 2011	K103710	WBR XPRESS PET	KPS	Substantially Equivalent	Ultraspect , Ltd.	accessdata.fda.gov
May 14, 2009	K091073	WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS	KPS	Substantially Equivalent	Ultraspect , Ltd.	accessdata.fda.gov
May 28, 2008	K081201	WBR XPRESS3.CARDIAC	KPS	Substantially Equivalent	Ultraspect , Ltd.	accessdata.fda.gov
April 2, 2008	K080784	WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE	KPS	Substantially Equivalent	Ultraspect , Ltd.	accessdata.fda.gov
April 26, 2005	K050815	XACT.CARDIAC & XPRESS.CARDIAC	KPS	Substantially Equivalent	Ultraspect , Ltd.	accessdata.fda.gov
March 11, 2004	K040370	WBR-FHR, WBR-FWB	KPS	Substantially Equivalent	Ultraspect , Ltd.	accessdata.fda.gov
July 18, 2003	K031874	MODIFICATION TO WBR, MODEL HR	KPS	Substantially Equivalent	U.C.G. Technologies , Ltd.	accessdata.fda.gov
April 9, 2003	K030870	WBR, MODEL HR	KPS	Substantially Equivalent	U.C.G. Technologies , Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 19, 2011. 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.