Not currently registered with FDA under this name

Suni Imaging Microsystems, Inc.

San Jose, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2002 and 2002. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12002–2002
Markets registered in: 33 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name Suni Imaging Microsystems, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Suni Imaging Microsystems, Inc.	1 clearances	2002–2002	Below
South Korea	MFDS	Manufacturer	Suni Imaging Microsystems, Inc	2	2004–2004	Pure Global AI
Taiwan	TFDA	Manufacturer	SUNI IMAGING MICROSYSTEMS, INC.	1	2007–2007	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 Imaging Microsystems, Inc. as the applicant.

Decided	510(k)	Device	Device type
15 Aug 2002	K021718	INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY	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.