Dental Device Guide
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Not currently registered with FDA under this name

Hitachi Medical Systems America, Inc.

Twinsburg, OH, United States. Named as applicant on 1 dental 510(k) clearance between 2003 and 2003. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12003–2003
Markets registered in
1United States
Establishments
0—
2003: 1200020102020

510(k) clearances per year, 2000–2026

510(k) clearances

Clearances on which FDA names Hitachi Medical Systems America, Inc. as the applicant.

Decided510(k)DeviceDevice type
20 Oct 2003K033248HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEMMUH 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.