Hitachi Medical Corp. of America

Tarrytown, NY, US

Hitachi Medical Corp. of America appears in FDA device records in Tarrytown, NY. FDA records list 32 510(k) clearances between 1985-02-25 and 2000-03-29, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 32
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 32 510(k) clearances for Hitachi Medical Corp. of America between 1985 and 2000. The busiest year on record is 1990, with 9. The most recent is 2000, with 1.

Clearances by year, as a table

510(k) clearance decisions for Hitachi Medical Corp. of America, by decision year
Year	Clearances
1985	1
1986	3
1987	2
1988	2
1990	9
1991	3
1992	1
1995	4
1996	1
1997	1
1998	1
1999	3
2000	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K994026	EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER	IYN	Substantially Equivalent	2000-03-29
K991535	CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS	KPS	Substantially Equivalent	1999-07-30
K991318	CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS	KPS	Substantially Equivalent	1999-06-18
K991129	HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL	KPS	Substantially Equivalent	1999-05-13
K981434	EUP-OL334 LAPARASCOPICPROBE	ITX	Substantially Equivalent	1998-07-27
K954220	EUB-8000	IYN	Substantially Equivalent	1997-05-07
K962308	EUB-905	IYO	Substantially Equivalent	1996-07-17
K954143	HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS	KPS	Substantially Equivalent	1995-12-22
K954129	SPECTRADIGITAL SERIES V250DSP	KPS	Substantially Equivalent	1995-12-22
K945400	HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100	IZI	Substantially Equivalent	1995-11-20
K945795	EUB-555A+	IYO	Substantially Equivalent	1995-10-27
K912364	ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED	ITX	Substantially Equivalent	1992-08-26
K912363	ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3	ITX	Substantially Equivalent	1991-08-27
K905294	EUB-315	IYO	Substantially Equivalent	1991-02-25
K896100	EUB-565 DIAGNOSTIC ULTRASOUND DEVICE	IYO	Substantially Equivalent	1991-01-24
K897042	EUB-515 DIAGNOSTIC ULTRASOUND DEVICE	IYO	Substantially Equivalent	1990-09-13
K900966	EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE	HGL	Substantially Equivalent	1990-09-12
K901658	ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND	DXK	Substantially Equivalent	1990-09-04
K901657	ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND	DXK	Substantially Equivalent	1990-09-04
K900683	SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND	ITX	Substantially Equivalent	1990-08-31
K890532	EUP-C321 5.0MHZ CONVEX TYPE PROBE	ITX	Substantially Equivalent	1990-04-13
K890531	EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE	ITX	Substantially Equivalent	1990-04-13
K884644	ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322	IYO	Substantially Equivalent	1990-04-13
K895326	EUB-165	DXK	Substantially Equivalent	1990-03-22
K874211	EUB-450 DIAGNOSTIC ULTRASOUND DEVICE	IYO	Substantially Equivalent	1988-06-23
K870878	EUB-305 DIAGNOSTIC ULTRASOUND DEVICE	DXK	Substantially Equivalent	1988-04-22
K871004	EUB-410 DIAGNOSTIC ULTRASOUND DEVICE	IYO	Substantially Equivalent	1987-12-11
K862867	EUB-310 ULTRASONIC SCANNER	IYO	Substantially Equivalent	1987-01-05
K863576	EUB-400 DIAGNOSTIC ULTRASOUND DEVICE	IYO	Substantially Equivalent	1986-12-12
K862165	ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340	IYO	Substantially Equivalent	1986-11-28
K862164	EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER	IYO	Substantially Equivalent for Some Indications	1986-11-04
K844128	EUB-40	JAF	Substantially Equivalent	1985-02-25

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

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