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Source-Ray, Inc.

USA · Ronkonkoma

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Russia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 9 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

3 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 8 510(k), 0 PMA, 33 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: Source-Ray, Inc. · SOURCE-RAY, INC.

FDA 510(k) clearances by year

12003

12004

12005

12006

12007

12009

12015

12016

FDA listed device types

Assembly, Tube Housing, X-Ray, Diagnostic 1System, X-Ray, Stationary 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K163063	UC-5000 Mobile X-Ray	2016-12-12
US	K133959	PODIATRY X-RAY SYSTEM	2015-01-22
US	K090655	PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260	2009-07-14
CA	90530	PORTABLE X-RAY SYSTEM SR-130	Class II

Source-Ray, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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