MULTIPLE MANUFACTURED BY PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND

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Request for Information Form	Contact Information
Company Name	PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
Address	ROENTGENSTRASSE 24
City, State, Zip	HAMBURG,
Country	GM
FDA Owner/Operator Phone	425-487-7000
FDA Medical Specialty Code	RA - Radiology
FDA Product Code	KPW
FDA Classification Name	DEVICE, BEAM LIMITING, X-RAY, DIAGNOSTIC
FDA Device Classification Code	Standards
FDA Regulation Number	892.1610
FDA Common Generic Name	X-RAY COLLIMATORS, BEAM-LIMTING DEVICES, VARIOUS MODELS
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	1217116
FDA Owner / Operator Name	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
FDA Establishment Registration Number	3003768251
FDA Registered Establishment Name	PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
FDA Operation Code(s)
FDA Listing Date	02-17-06
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	CARESTREAM HEALTH, INC. 1669 LAKE AVE. ROCHESTER, NY 14652 US / 585-724-5974	EASTMAN KODAK DENTAL X-RAY BEAM FILTER	DENTAL BEAM FILTER
2	DENTALEZ GROUP, STARDENTAL DIVISION 1816 COLONIAL VILLAGE LN. LANCASTER, PA 17601 US 610-725-8004 312 / 717-291-1161 4350	LONG & SHORT RECTANGULAR CONES	RECTANGULAR POSITION INDICATING DEVICE
3	SIEMENS AG, MEDICAL SOLUTIONS ROENTGENSTRASSE 2 RUDOLSTADT, 07407 GM / 610-448-4153	MULTIPLE	BEAM LIMITING DEVICE
4	SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MALVERN, PA 19355 US 610-219-6300 / 610-448-4153		BEAM LIMITING DEVICE
5	UMI INTL. 2 E. UNION AVE. P.O. BOX 170 EAST RUTHERFORD, NJ 07073 US 201-804-8044 / 201-804-8044	X-RAY COLLIMATOR	COLLIMATOR
6	UNIQUE MEDICAL IMAGING UNIT 101, 964-12 SINWOL 7-DONG YANGCHUN-KU SEOUL, KS 02-269-8 7200 / 201-804-8044	X-RAY COLLIMATOR	COLLIMATOR
7	VACUTEC MESSTECHNIK GMBH DORNBLUTHSTR.14 DRESDEN, D-01277 GM 004-937-166660 / 004-935-13172422	MULTIPLE	VARIOUS
8	VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 BUCCINASCO, 20090 IT 914-686-3600 / 847-288-7000 7948	MULTIPLE	BEAM LIMITING DEVICE