MULTIPLE MANUFACTURED BY PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND

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MULTIPLE

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	JAA
FDA Classification Name	SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
FDA Device Classification Code	Standards
FDA Regulation Number	892.1650
FDA Common Generic Name	IMAGE INTENSIFIED FLUOROSCOPIC SYSTEMS, COMPONENTS
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)	MM - Manufacturer
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

Competitors of PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND

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	ABSOLUTE X-RAY IMAGING 205 NORTH LITTLE TOR RD. NEW CITY, NY 10956 US 914-638-8080 / 914-638-8080	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
2	ACCELLENT INC. 1526-6 CALLE HERTZ JUAREZ, CHIHUAHUA, 32470 MX 866-899-1392 / 915-782-1944	SMITH & NEPHEW CDS SYSTEM	DISPOSABLE SET, CDS
3	AFP IMAGING CORP. 250 CLEARBROOK RD. ELMSFORD, NY 10523 US 914-592-6100 / 914-592-6100	MTT-90 REMOTE CONTROLLED R/F SYSTEM	REMOTE CONTROL FLUOROSCOPY SYSTEM
4	ANEXA CORPORATION 8 CENTENNIAL DR. PEABODY, MA 01960 US 978-326-4000 / 978-326-4619	ANEXA ORBIS C AND ANEXA ORBIS ED	MOBILE FLUOROSCOPIC X-RAY SYSTEMS
5	BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. SAN JOSE, CA 95134 US 508-652-5594 / 508-652-5594	MAP	DC-COUPLED, ISOLATED PREAMPLIFIER
6	BRAND X-RAY CO., INC. 910 WESTWOOD AVE. ADDISON, IL 60101 US 630-543-5331 / 630-543-5331		TUBE, X-RAY
7	CANON U.S.A., INC. ONE CANON PLAZA LAKE SUCCESS, NY 11042 US 81-3-3758 2111 / 516-328-5602	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
8	COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. 45 RIVER DRIVE GEORGETOWN,ONTARIO, L7G 2J4 CA 905-877-0161 / 905-877-0161	CPIVISION DIGITAL IMAGING SYSTEM	DIGITAL IMAGING SYSTEM
9	DIREX SYSTEMS CORP. 437 TURNPIKE ST. CANTON, MA 02021 US 339-502-6013 / 888-874-7837	VERT-X	VARIOUS TYPES OF FLUOROSCOPIC X-RAY SYSTEMS
10	DMX-WORKS, INC. 4159-B CORPORATE COURT PALM HARBOR, FL 34683 US 800-839-6757 / 800-839-6757	DIGITAL MOTION X-RAY SYSTEM	VARIOUS MODELS OF DIGITAL MOTION X-RAY SYSTEMS
11	GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO.1, YONG CHANG NORTH RD. BEIJING ECON.&TECH.DEV.ZONE BEIJING PR, 100176 CH 847-277-5002 / 262-544-3894	MULTIPLE	TYPES OF IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEMS
12	GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 847-277-5002 / 262-544-3894	POLARIX	MOBILE IMAGE INTENSIFIER UNIT
13	GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. SALT LAKE CITY, UT 84116 US 847-277-5002 / 801-517-6440	MULTIPLE	IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
14	GE OEC MEDICAL SYSTEMS GMBH 14 WILHELM-MAISEL-STR. WENDELSTEIN, D-90530 GM 847-277-5002 / 801-536-4977	OEC 7700, SERIES, COMPACT & COMPACT PLUS/FLUOROSTAR/7600,COMPACT/7600, SERIES	MOBILE C-ARM
15	GENERAL MEDICAL MERATE S.P.A. VIA PARTIGIANI, 25 SERIATE, BERGAMO, 24068 IT / 720-962-5412	MULTIPLE	VARIOUS MODELS OF IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEMS
16	HAMAMATSU PHOTONICS, K.K. 325-6 SUNAYAMA-CHO HAMAMATSU CITY, 430 JA 81-534-52-2141 / 908-231-0960 2300	NO PROPRIETARY NAME LISTED	X-RAY IMAGE INTENSIFIER
17	HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 US 781-999-7300 / 781-999-7368	FLUORO SCAN IMAGING SYSTEM	FLUOROSCOPE
18	IMAGE DIAGNOSTICS, INC. 98 PRATTS JUNCTION RD. STERLING, MA 01564 US 978-422-8601 / 978-422-8601	ID400 SERIES ARMBOARDS	ARBOARDS
19	INFIMED, INC. 121 METROPOLITAN DR. LIVERPOOL, NY 13088 US 315-453-4545 / 315-453-4545 323	ORION DIGITAL IMAGING SYSTEM	X-RAY SYSTEM
20	INTEGRATED TECHNOLOGIES OF SOUTHWEST FLORIDA, INC. 3800 FOWLER ST., UNIT 1 FORT MYERS, FL 33901 US 239-275-4888 / 239-275-4888	MULTIPLE	VARIOUS
21	INTEGRITY PRACTICE MANAGEMENT, INC. 7501 E HIGHWAY 42 SIOUX FALLS, SD 57110 US / 605-728-1976	VARIOUS MODELS OF C-ARMS	C-ARM
22	LAKESHORE TECHNOLOGIES INC. 7536 MURRAY DR. CICERO, NY 13039 US 315-699-2975 / 315-699-2975	FLUORECORD MODEL 762	DIGITAL SPOT SYSTEM
23	LIFECARE IMAGING INTL., LTD. 8411 PYOTT RD. LAKE IN THE HILLS, IL 60102 US 815-477-1291 / 815-477-1291	V7SS IMAGER	MOBILEFLUOROSCOPIC C-ARM
24	LIXI, INC. 11980 OAK CREEK PARKWAY HUNTLEY, IL 60142 US 847-961-6666 225 / 847-961-6666 225	LIXISCOPE	VARIOUS MODELS OF LIXISCOPE
25	MEDICAL TECHNIQUES, INC. 125 NORTH 400 WEST, STE, C NORTH SALT LAKE, UT 84054 US / 801-936-4501	ARTHROGRAM TRAY	ARTHROGRAM TRAY/KIT/PACK
26	MEDISONXRAY CO., LTD. 251-30, MOKDONG-RI, GYOHA-EUP PAJU, GYEONGGI-DO, 413-833 KS 82-2-21943221 / 82-2-21943221	MCA-6100 MOBILE C-ARM	MCA-6100 MOBILE C-ARM
27	MINRAD, INC. 50 COBHAM DR. ORCHARD PARK, NY 14127 US 716-855-1068 / 716-855-1068	DRTS	REMOTE CONTROL DRAPE
28	NICAL SPA 43 VIA SOFFREDINI MILAN (MI), 20126 IT 39-02-2571110 / 914-275-7679	MULTIPLE MODELS	FLUOROSCOPIC IMAGING SYSTEMS
29	NRT-NORDISK RONTGEN TEKNIK A/S BIRKEGAARDSVEJ 16 HASSELAGER, 8361 DA 458-628-3500 / 720-962-5412	MULTIPLE	VARIOUS MODELS OF IMAGE0INTESIFIED FLOUROSCOPIC X-RAY SYSTEMS
30	OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE SANFORD, FL 32771 US 407-323-9400 / 407-323-9400	E-VIEW FLUOROSCOPY SYSTEM	SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE INTENSIFIED
31	PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. 1 ORG SANAYI BOLGES ORHAN ISIK CAD 4 SINCAN ANKARA, 06935 TU 90-312-2672046 / 90-312-2672046	UROVANTAGE/MULTIVANTAGE	UROLOGICAL TABLE
32	PERKINS ELECTRONICS CO. 1510 N.WASHINGTON AVE. DALLAS, TX 75204 US 214-828-4545 / 214-828-4545 109	MULTIPLE	VIDEO CONTROLLER
33	PHILIPS MEDICAL SYSTEMS JAN CAMPERTSTRAAT 5 HEERLEN, 6416-SG NL 425-487-7000 / 978-659-4663	MULTIPLE	IMAGE INTENSIFIED FLUOROSCOPIC SYSTEMS, COMPONENTS PARTS AND ACCESSORIES
34	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 BEST, 5684 PC NL 425-487-7000 / 978-659-4663	MULTIPLE	FLUOROSCOPIC X-RAY SYSTEM
35	PRECISE OPTICS 239 SOUTH FEHR WAY BAY SHORE, NY 11706 US 631-242-6600 / 631-242-6600	FLUROSCOPIE X-RAY SYSTEM, AUTOMATIC BRIGHTNESS STABILIZER	FLUOROSCOPIC X-RAY SYSTEM, AUTOMATIC BRIGHTNESS STABILIZER
36	PREFERRED MEDICAL PRODUCTS 191 INDUSTRIAL DR. DUCKTOWN, TN 37326 US 423-496-3738 / 423-496-3738	EAZY COVERS	VARIOUS STERILE EQUIPMENT COVERS
37	QR S.R.L. VIA SILVESTRINI 20 VERONA, VR, 37135 IT 914-592-6100 / 39-045-8202727	NEWTOM 3G QR-DVT 9000	COMPUTED TOMOGRAPHY X-RAY SYSTEM
38	SIEMENS AG, MEDICAL SOLUTIONS SIEMENSSTRASSE 1 FORCHHEIM, 91301 GM / 610-448-4153	MULTIPLE	IMAGE INTENSIFIED X-RAY SYSTEM
39	SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 ERLANGEN, 91052 GM / 610-448-4153	MULTIPLE	IMAGE INTENSIFIED X-RAY SYSTEM
40	SIMAD MEDICAL TECHNOLOGY SRL VIA MARSALA 29 MIRANDOLA, MO, 41037 IT 011- 39-053524305 / 39-05-3524305	SIMAD MEDICAL TECHNOLOGY	MOBILE C-ARM
41	SMITH & NEPHEW INC., ENDOSCOPY DIV. 76 S. MERIDIAN AVE. OKLAHOMA CITY, OK 73107 US 978-749-1000 / 978-749-1073	SMITH & NEPHEW CDS DISCOGRAPHY SYSTEM	DISCOGRAPHY SYSTEM
42	STORZ MEDICAL AG LOHSTAMPFESTRASSE 8 TAGERWILEN, CH-8274 SZ 41-071-677 45 45 / 678-354-6229 8812	STORZ MEDICAL X-RAY SYSTEM XR-MX	IMAGE INTENSIFIED FLUOROSCOPIC X-RAY C-ARM
43	STRYKER ENDOSCOPY 5900 OPTICAL CT. SAN JOSE, CA 95138 US 269-385-2600 / 408-754-2124	SONY 3500 VHS VCR	VCR
44	SUINSA C/. PRIMAVERA, 39 PARQUE IND. LAS MOJAS TORREJON DE ARDOZ MADRID, 28850 SP 34-916-55 9500 / 847-374-8854	MULTIPLE	IMAGE INTENSIFIED X-RAY SYSTEM
45	TECHNIX S.P.A. VIA FERMI 26 GRASSOBBIO, BG, 24050 IT	PROFILE	MOBILE C-ARM IMAGING SYSTEM
46	THALES ELECTRON DEVICES CORP. 2 BIS RUE LATECOERE VELIZY, 78941 FR 33-130-703500 / 973-812-9000	X-RAY IMAGE INTENSIFIER TUBE IN ALUMINUM HOUSING	VARIOUS MODELS OF X-RAY IMAGE INTENSIFIER TUBES
47	TIDI PRODUCTS, LLC 570 ENTERPRISE DR. NEENAH, WI 54956 US 920-751-4300 / 920-751-4380		DRAPE FOR IMAGE INTENSIFIER, FLUOROSCOPE
48	TOSHIBA MEDICAL SYSTEMS CORPORATION 1385, SHIMOISHIGAMI OTAWARA-SHI, TOCHIGI, 324-8550 JA / 714-730-5000 7808	MULTIPLE	VARIOUS MODELS OF FLUOROSCOPIC SYSTEMS
49	VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 BUCCINASCO, 20090 IT 914-686-3600 / 847-288-7000 7948	MULTIPLE	FLUROSCOPIC X-RAY SYSTEM
50	WORLD TECHNOLOGIES, INC. 708-6 DIAMOND LAKE RD. MUNDELEIN, IL 60060 US 847-949-4948 / 847-949-4948	PATHFINDER	MOBILE C-ARM
51	XTEC, INC. 2090 WEST DOWELL RD. COLUMBIA CITY, IN 46725 US 219-244-5400 / 219-244-5400		REBUILD DENTAL X-RAY TUBE ASSEMBLIES
52	ZIEHM IMAGING GMBH DONAUSTRASSE 31 NUERNBERG, BAVARIA, 90451 GM 49-911-2172219 / 49-911-2172219	ZIEHM 7000 / ZIEHM VISTA	MOBILE SURGICAL C-ARM
53	ZIEHM IMAGING, INC. 4181 LATHAM ST. RIVERSIDE, CA 92501 US 951-781-2020 / 951-781-2020 140	ZIEHM VARIO-3D,VISION R,VISION FD	DIGITAL MOBILE IMAGING SYSTEM