Not currently registered with FDA under this name

Humanray Co,Ltd

Houston, TX, United States. Named as applicant on 1 dental 510(k) clearance between 2012 and 2012. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12012–2012
Markets registered in
34 registrations outside the US
Establishments
0—
2012: 120102020

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name Humanray Co,Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesCanada: 3 registrationsPeru: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantHumanray Co,Ltd1 clearances2012–2012Below
CanadaHealth CanadaRegistration holderHUMANRAY CO., LTD.32008–2010Pure Global AI
PeruDIGEMIDManufacturerHUMANRAY CO., LTD.12012–2012Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Humanray Co,Ltd as the applicant.

Decided510(k)DeviceDevice type
7 Feb 2012K113360MEDICAL IMAGE PROCESSING UNITEAP Intraoral X-Ray Unit

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.