Not currently registered with FDA under this name

Instrumentarium Corp. Imaging Division

Milwaukee, WI, United States. Named as applicant on 1 dental 510(k) clearance between 2005 and 2005. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12005–2005
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Instrumentarium Corp. Imaging Division 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	Instrumentarium Corp. Imaging Division	1 clearances	2005–2005	Below
South Korea	MFDS	Manufacturer	Instrumentarium Corp. Imaging Division	1	2000–2000	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 Instrumentarium Corp. Imaging Division as the applicant.

Decided	510(k)	Device	Device type
9 Feb 2005	K043612	ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D	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.