Not currently registered with FDA under this name
Suni Medical Imaging, Inc.
San Jose, CA, United States. Named as applicant on 4 dental 510(k) clearances between 2006 and 2016. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42006–2016
- Markets registered in
- 423 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Suni Medical Imaging, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Suni Medical Imaging, Inc. | 4 clearances | 2006–2016 | Below |
| Canada | Health Canada | Registration holder | SUNI MEDICAL IMAGING, INC. | 19 | 2007–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Suni Medical Imaging, Inc.SUNI MEDICAL IMAGING, INC | 3 | 2010–2015 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Suni Medical Imaging, Inc. | 1 | — | 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 Suni Medical Imaging, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Nov 2016 | K162585 | SuniIQ Digital Radiography System | MUH Digital Extraoral Source X-Ray System |
| 2 Jun 2009 | K083917 | X-RAY, TOMOGRAPHY, COMPUTED, DENTAL | OAS Dental Computed Tomography X-Ray |
| 7 Feb 2007 | K070219 | SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 3 Feb 2006 | K060149 | SUNIPAN IMAGING SYSTEM & ACCESSORIES | MUH Digital Extraoral Source X-Ray System |
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.