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Advanced Imaging Services, Inc.: FDA-registered device maker in Lathrop, CA, United States, 9 510(k) clearances

Name: Advanced Imaging Services, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Advanced Imaging Services, Inc. is registered with the FDA (registration 3012085143) in Lathrop, CA, United States. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 30, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012085143
Address: 17410 Murphy Pkwy, Lathrop, CA, United States, 95330
Owner or operator: Advanced Imaging Services, inc. (10080696)
Roles: Repackager or relabeler
First device listed: December 21, 2022
Registered through: 2026
Brand names listed: Biograph MMR, GE Injector CT Motion, GE Signa HDxt 1.5T MRI, Medrad Stellant D, Siemens Biography Horizon - Dura688, Siemens Pro.Specta, TEST

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Repackager or relabeler	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Repackager or relabeler	accessdata.fda.gov
Injector, Contrast Medium, Automatic	IZQ	2	Repackager or relabeler	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Repackager or relabeler	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Repackager or relabeler	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Repackager or relabeler	accessdata.fda.gov
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	OUO	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
October 30, 2024	K243186	Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
August 6, 2021	K210541	ulrichINJECT CT motion	IZQ	Substantially Equivalent	Ulrich GmbH & Co. KG	accessdata.fda.gov
June 1, 2017	K170904	Biograph Horizon PET/CT	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
March 17, 2017	K163331	Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
March 21, 2014	K133657	DISCOVERY PET/CT 710	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 20, 2012	K121676	1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
June 8, 2011	K103429	BIOGRAPH MMR	OUO	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
September 2, 2008	K082104	GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM	JAK	Substantially Equivalent	Ge Medical Systems, Inc.	accessdata.fda.gov
March 2, 2004	K033881	MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE	DXT	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 30, 2024. 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.