Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005625991

FEI Number

3005625991

Entity Name

FUJIFILM Healthcare Americas Corporation

City/State/Country

Edison, NJ, US

Establishment Address

1100 King Georges Post Rd, Edison, NJ 08837, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

FUJIFILM CORPORATION (Owner Number: 8031568)

Owner / Operator Contact Address

26-30, Nishiazabu 2-chome, MINATO-KU, JP-13 106-8620, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K001005

PMA Number

N/A

All Registered Proprietary Names

NEFA Standard Solution Multi-Calibrator Lipids uTASWako DCP uTASWako AFP-L3 NEFA Linearity Material Wako HDL-C/LDL-C Calibrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-04-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-04-28
OUE	Micro Total Analysis Instrument System	Clinical Chemistry	Class 2	862.2570	2014-01-31
OAU	Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma	Immunology	Class 2	866.6030	2014-01-31
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-01-31
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-01-31
NSF	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment	Immunology	Class 2	866.6030	2014-01-31
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-04-28
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-04-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FUJIFILM CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020707080	FUJIFILM medwork GmbH	Hochstadt/Aisch Bavaria, DE
3008787461	FUJIFILM Imaging System (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
2155	FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office	MINAMIASHIGARA-SHI Kanagawa, JP
3034364687	FUJIFILM Corporation Material Manufacturing Headquarters	Fujinomiya Shizuoka, JP
3003706548	FUJIFILM MATERIAL MANUFACTURING CO., LTD. Shizuoka Area	Fujinomiya Shizuoka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233629	FUJIFILM Healthcare Americas Corporation	APERTO Lucent MRI System	2024-05-10
K233687	FUJIFILM Healthcare Americas Corporation	ECHELON Synergy V10.0	2024-05-03
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2026	FUJIFILM Healthcare Americas Corporation	2	FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Z-1171-2024	FUJIFILM Healthcare Americas Corporation	2	Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
Z-1172-2024	FUJIFILM Healthcare Americas Corporation	2	Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Z-1268-2024	FUJIFILM Healthcare Americas Corporation	2	Synapse PACS - Version 7.1.000
Z-1269-2024	FUJIFILM Healthcare Americas Corporation	2	Synapse PACS - Version 7.1.000US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005625991. Last updated year: 2026. Please use registration number 3005625991 when referencing this establishment in official correspondence.