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Source-Ray, Inc.: FDA-registered device maker in Ronkonkoma, NY, United States, 6 510(k) clearances

Name: Source-Ray, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Source-Ray, Inc. is registered with the FDA (registration 3004606964) in Ronkonkoma, NY, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 12, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004606964
Address: 50 Fleetwood Ct, Ronkonkoma, NY, United States, 11779
Owner or operator: Source-Ray, Inc. (10021863)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: October 3, 2007
Registered through: 2026
Brand names listed: Optional Remote Control, PXS-710D, PowerMax 1260, RC-115, SB-60-333, SR-115, SR-130, UC-5000 and more

Devices it lists

Device	Product code	Class	Role	Source
Assembly, Tube Housing, X-Ray, Diagnostic	ITY	1	Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Complaint file establishment, Contract manufacturer, 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
December 12, 2016	K163063	UC-5000 Mobile X-Ray	IZL	Substantially Equivalent	Source-Ray, Inc.	accessdata.fda.gov
January 22, 2015	K133959	PODIATRY X-RAY SYSTEM	KPR	Substantially Equivalent	Source-Ray, Inc.	accessdata.fda.gov
July 14, 2009	K090655	PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260	IZL	Substantially Equivalent	Source-Ray, Inc.	accessdata.fda.gov
October 31, 2006	K062472	OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115	IZL	Substantially Equivalent	Source-Ray, Inc.	accessdata.fda.gov
August 11, 2005	K052001	MODEL SR-115 PORTABLE X-RAY SYSTEM	IZL	Substantially Equivalent	Source-Ray, Inc.	accessdata.fda.gov
May 20, 2003	K030494	SR-130	IZL	Substantially Equivalent	Source-Ray, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 12, 2016. 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.