MULTIPLE MANUFACTURED BY GE MEDICAL SYSTEMS SCS

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Request for Information Form	Contact Information
Company Name	GE MEDICAL SYSTEMS SCS
Address	283 RUE DE LA MINIERE BP 34
City, State, Zip	BUC CEDEX,
Country	FR
FDA Owner/Operator Phone	847-277-5002
FDA Medical Specialty Code	RA - Radiology
FDA Product Code	MUE
FDA Classification Name	FULL FIELD DIGITAL,SYSTEM,X-RAY,MAMMOGRAPHIC
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	FULL FIELD DIGITAL MAMMOGRAPHY
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	9912004
FDA Owner / Operator Name	GENERAL ELECTRIC CO.
FDA Establishment Registration Number	9611343
FDA Registered Establishment Name	GE MEDICAL SYSTEMS SCS
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-23-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	FUJIFILM CORPORATION 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA, 258-8538 JA 813-340-62473 / 203-324-2000 3664	FCRMS FUJI COMPUTED RADIOGRAPHY MAMOMOGRAPHY SUITE	DIGITAL MAMMOGRAPHY SYSTEM
2	FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. STAMFORD, CT 06902 US 813-340-62473 / 203-324-2000 3664	FCRMS FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE	DIGITAL MAMMOGRAPHY SYSTEM
3	LORAD, A HOLOGIC CO. 37 APPLE RIDGE RD. DANBURY, CT 06810 US 781-999-7300 / 781-999-7368	SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	FULL FIELD DIGITAL SYSTEM X-RAY MAMMOGRAPHIC
4	LORAD, A HOLOGIC CO. 36 APPLE RIDGE RD. DANBURY, CT 06810 US 781-999-7300 / 781-999-7368	SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	FULL FIELD DIGITAL SYSTEM X-RAY MAMMOGRAPHIC
5	SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 ERLANGEN, 91052 GM / 610-448-4153	MULTIPLE	MAMMOMAT