Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004606964

FEI Number

3004606964

Entity Name

Source-Ray, Inc.

City/State/Country

Ronkonkoma, NY, US

Establishment Address

50 Fleetwood Ct, Ronkonkoma, NY 11779, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Source-Ray, Inc. (Owner Number: 10021863)

Owner / Operator Contact Address

50 Fleetwood Court, Ronkonkoma, NY 11779, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030494

PMA Number

N/A

All Registered Proprietary Names

SR-115 XRS-140-15K-P XRS-140-7.5K-P XRS-125-7K-P PowerMax 1260 SR-130

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2007-10-03
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2008-12-11
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2008-12-11
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2010-09-14
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2007-10-03

Official Correspondent

Theophilos Theophilou

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Source-Ray, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004606964. Last updated year: 2026. Please use registration number 3004606964 when referencing this establishment in official correspondence.