Not currently registered with FDA under this name

Nanoray Co., Ltd.

Daegu, South Korea. Named as applicant on 1 dental 510(k) clearance between 2020 and 2020. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12020–2020
Markets registered in
45 registrations outside the US
Establishments
0—
2020: 120102020

510(k) clearances per year, 2007–2026

Registered in 4 markets

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

All markets
United States: 1 clearancesEuropean Union: 3 registrationsAustralia: 1 registrationsSaudi Arabia: 1 registrations
RegisteredHome: South KoreaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantNanoray Co., Ltd.1 clearances2020–2020Below
European UnionEUDAMEDManufacturerNANORAY Co.,Ltd.3—Pure Global AI
AustraliaTGAManufacturerNanoray Co Ltd12023–2023Pure Global AI
Saudi ArabiaSFDAManufacturerNANORAY Co Ltd1—Pure 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 Nanoray Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
28 Dec 2020K201800Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)EHD Extraoral with Timer 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.