Hitachi Healthcare Americas Corp

FDA Filings

This page includes the latest FDA filings for Hitachi Healthcare Americas Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Hitachi Healthcare Americas Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP

FDA Registration(s)

• Registration Number: 3011617252
• FEI Number: 3011617252
• Name: Hitachi Healthcare Americas Corp. Informatics Division
• Owner & Operator: HITACHI HEALTHCARE AMERICAS CORPORATION
• Contact Address: 1959 SUMMIT COMMERCE PARK --; Twinsburg OH 44087 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 204 Westfield Street ; Greenville, SC 29601 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 1528028
• FEI Number: 1528028
• Name: HITACHI HEALTHCARE AMERICAS CORPORATION
• Owner & Operator: HITACHI HEALTHCARE AMERICAS CORPORATION
• Contact Address: 1959 SUMMIT COMMERCE PARK --; Twinsburg OH 44087 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1959 SUMMIT COMMERCE PARK ; TWINSBURG, OH 44087 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00860007188336 HITACHI HEALTHCARE AMERICAS CORPORATION	UST-52114P-B	2021-07-09
GUDID 00860007188329 HITACHI HEALTHCARE AMERICAS CORPORATION	UST-9150	2021-07-09
GUDID 00860007188312 HITACHI HEALTHCARE AMERICAS CORPORATION	UST 5550-R	2021-07-09
GUDID 00860007188305 HITACHI HEALTHCARE AMERICAS CORPORATION	C9150LA	2021-07-09
GUDID 00869047000462 HITACHI HEALTHCARE AMERICAS CORPORATION	D&K Technologies	2021-02-23
GUDID 00869047000455 HITACHI HEALTHCARE AMERICAS CORPORATION	D&K Technologies	2021-02-23
GUDID 00869047000448 HITACHI HEALTHCARE AMERICAS CORPORATION	HITACHI HEALTHCARE AMERICAS	2020-07-07
GUDID 00869047000431 HITACHI HEALTHCARE AMERICAS CORPORATION	VidiStar PACS & DICOM Viewer Software	2019-05-23
GUDID 00869047000424 HITACHI HEALTHCARE AMERICAS CORPORATION	HITACHI HEALTHCARE AMERICAS	2018-08-23
GUDID 00869047000417 HITACHI HEALTHCARE AMERICAS CORPORATION	HITACHI HEALTHCARE AMERICAS	2018-08-23
GUDID 00869047000400 HITACHI HEALTHCARE AMERICAS CORPORATION	HITACHI HEALTHCARE AMERICAS	2018-08-23
PMN K181376 Hitachi Healthcare Americas Corporation	ARIETTA 65	2018-07-18
PMN K173739 Hitachi Healthcare Americas Corporation	ALOKA ARIETTA 850	2018-02-28
PMN K083910 | LLZ Hitachi Healthcare Americas Corp. Informatics Division [HITACHI HEALTHCARE AMERICAS CORPORATION]	VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER	2018-01-24
PMN K083910 | DQK Hitachi Healthcare Americas Corp. Informatics Division [HITACHI HEALTHCARE AMERICAS CORPORATION]	VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER	2018-01-24
PMN K172110 Hitachi Healthcare Americas Corporation	ECHELON OVAL V6.0A MRI System	2018-01-11
PMN K171708 Hitachi Healthcare Americas Corporation	ALOKA ARIETTA 850	2017-10-31
PMN K171738 Hitachi Healthcare Americas Corporation	Supria True64	2017-08-18
GDF HITACHI HEALTHCARE AMERICAS CORPORATION	BREAST COIL BIOPSY MECHANISM, OASIS	2008-02-01

Related Finance Registrations

NCAGE Code	1SNJ0	HITACHI HEALTHCARE AMERICAS!CORPORATION
CAGE Code	1SNJ0	HITACHI HEALTHCARE AMERICAS CORPORATION
S.A.M. Registration	1SNJ0 [603156043]	HITACHI HEALTHCARE AMERICAS CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020022957519	Hamilton,Bermuda -> New York/Newark Area, Newark, New Jersey	TOOLS AND EQUIPMENT	10 CNT
2020022957519	Hamilton,Bermuda -> New York/Newark Area, Newark, New Jersey	TOOLS AND EQUIPMENT	10 CNT