Hitachi Medical Corp.

Tarrytown, NY, US

Hitachi Medical Corp. appears in FDA device records in Tarrytown, NY. FDA records list 12 510(k) clearances between 1982-07-13 and 2016-10-18, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 12
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 12 510(k) clearances for Hitachi Medical Corp. between 1982 and 2016. The busiest year on record is 2001, with 2. The most recent is 2016, with 1.

Clearances by year, as a table

510(k) clearance decisions for Hitachi Medical Corp., by decision year
Year	Clearances
1982	1
1991	1
1994	1
2001	2
2002	2
2004	1
2005	1
2006	1
2008	1
2016	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K160559	NOBLUS™ Ultrasound Diagnostic System	IYN	Substantially Equivalent	2016-10-18
K073310	OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL	MOS	Substantially Equivalent	2008-01-18
K061608	MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER	IYN	Substantially Equivalent	2006-11-22
K053258	EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER	IYN	Substantially Equivalent	2005-12-09
K042501	ETG-4000 OPTICAL TOPOGRAPHY SYSTEM	DQA	Substantially Equivalent	2004-10-12
K013722	MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER	IYN	Substantially Equivalent	2002-02-11
K013723	MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER	ITX	Substantially Equivalent	2002-02-06
K012239	MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM	IYN	Substantially Equivalent	2001-08-10
K011252	EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM	IYO	Substantially Equivalent	2001-05-30
K926209	EUB-555	IYO	Substantially Equivalent	1994-06-03
K910268	TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T	ITX	Substantially Equivalent	1991-04-15
K827377	MODEL LS 3000 LINEAR SCANNER		Substantially Equivalent	1982-07-13

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain