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FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office: FDA-registered device maker in MINAMIASHIGARA-SHI Kanagawa, Japan, 3 510(k) clearances

Name: FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office is registered with the FDA (registration 2155) in MINAMIASHIGARA-SHI Kanagawa, Japan. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 22, 2007. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 2155
Address: 1250 Takematsu, MINAMIASHIGARA-SHI Kanagawa, Japan, 250-0111
Owner or operator: FUJIFILM CORPORATION (8031568)
Roles: Contract manufacturer, Manufacturer
First device listed: April 4, 2007
Registered through: 2026
Brand names listed: FCR CARBON (CR-IR357), FCR CARBON XL-2 (CR-IR359), FCR PRIMA Tm(CR-IR392), FCR Prima T(CR-IR392), FCR Prima T2 (CR-IR392), FCR Prima T2(CR-IR392), FCR XC-2 (CR-IR357), FCR XL-2 (CR-IR359) and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer	accessdata.fda.gov
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma	OAU	2	Contract manufacturer	accessdata.fda.gov
Micro Total Analysis Instrument System	OUE	2	Contract manufacturer	accessdata.fda.gov
Screen, Intensifying, Radiographic	EAM	1	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Contract manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment	NSF	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 22, 2007	K070920	FUJI IP CASSETTE TYPE PC	IYE	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.	accessdata.fda.gov
August 25, 2004	K042023	FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER	MQB	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.	accessdata.fda.gov
February 26, 1987	K862414	FUJI CR IMAGING PLATE	EAM	Substantially Equivalent	Parexel Intl. Corp.	accessdata.fda.gov

Compare with other makers

Updated May 22, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.