Not currently registered with FDA under this name
Imaging Sciences International
Hatfield, PA, United States. Named as applicant on 2 dental 510(k) clearances between 2014 and 2016. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22014–2016
- Markets registered in
- 35 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Imaging Sciences International 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 | Imaging Sciences International | 2 clearances | 2014–2016 | Below |
| Taiwan | TFDA | Manufacturer | Imaging Sciences International, LLCIMAGING SCIENCES INTERNATIONAL INC. · IMAGING SCIENCES INTERNATIONAL, LLC | 4 | 2005–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Imaging Sciences International | 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 Imaging Sciences International as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Nov 2016 | K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | OAS Dental Computed Tomography X-Ray |
| 14 May 2014 | K133620 | CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM | OAS Dental Computed Tomography X-Ray |
Some of these clearances are listed with FDA today by another company: Dental Imaging Technologies Corporation (1).
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.