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MULTIPLE
 Request for Information Form |
 Contact Information
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| Company Name | GE MEDICAL SYSTEMS, LLC |
| Address | 3000 N GRANDVIEW BLVD. |
| City, State, Zip | WAUKESHA, WI 53188 |
| Country | US |
| FDA Owner/Operator Phone | 847-277-5002 |
| FDA Medical Specialty Code | RA - Radiology |
| FDA Product Code | MQB |
| FDA Classification Name | SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 892.1650 |
| FDA Common Generic Name | VARIOUS MODELS OF DIGITAL RADIOGRAPHIC IMAGING SYSTEMS |
| FDA Proprietary Device Name | MULTIPLE |
| FDA Owner / Operator Number | 9912004 |
| FDA Owner / Operator Name | GENERAL ELECTRIC CO. |
| FDA Establishment Registration Number | 2126677 |
| FDA Registered Establishment Name | GE MEDICAL SYSTEMS, LLC |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 06-20-00 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of GE MEDICAL SYSTEMS, LLC
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 | AGFA HEALTHCARE CORP. 10 SOUTH ACADEMY ST. GREENVILLE, SC 29601 US 011-323-4447064 / 864-421-1815 |
MULTIPLE | VARIOUS TYPES OF SOLID STAT X-RAY IMAGERS |
| 2 | AGFA HEALTHCARE GMBH TEGERNSEER LANDSTRASSE 161 MUNICH, D81586 GM 011-323-4447064 / 864-421-1815 |
MULTIPLE | VARIOUS TYPES OF SOLID STAT X-RAY IMAGERS |
| 3 | AGFA HEALTHCARE GMBH MAX PLANCK STRASSE 1 PEISSENBERG, D82380 GM 011-323-4447064 / 864-421-1815 |
MULTIPLE | VARIOUS TYPES OF SOLID STAT X-RAY IMAGERS |
| 4 | AGFA HEALTHCARE N.V. SEPTESTRAAT 27 MORTSEL, B 2640 BE 011-323-4447064 / 864-421-1815 |
MULTIPLE | VARIOUS TYPES OF SOLID STAT X-RAY IMAGERS |
| 5 | AIR TECHNIQUES, INC. 1295 WALT WHITMAN RD. MELVILLE, NY 11747 US 800-247-8324 / 516-214-5514 |
SCANX 12 (A8200), SCANX 14 (B2100), SCANX 17 (B2100CC) | SCANNER FOR COMPUTED RADIOGRAPHY |
| 6 | ALARA, INC. 47505 SEABRIDGE DRIVE FREMONT, CA 94538 US 510-315-5200 / 510-315-5189 |
CRYSTALVIEW CR SYSTEM | COMPUTED RADIOGRAPHY SYSTEM |
| 7 | ANRAD CORP. 4950, RUE LEVY SAINT-LAURENT, QUEBEC, H4R 2P1 CA 978-326-4000 / 514-856-6921 |
ANRAD GR 17 | FLAT PANEL DIGITAL IMAGER |
| 8 | BIOSCAN SA 27, PRE BOUVIER MEYRIN, GENEVA, 1217 SZ 011-41-227851700 / 212-305-1831 |
SOLID STATE X-RAY IMAGING DEVICE (MULTIPLE BRANDS) | SOLID STATE X-RAY IMAGING DEVICE (VARIOUS TYPES) |
| 9 | CANON INC. 22-2 KIYOHARA-KOGYOUDANCHI UTSUNOMIYA-SHI, 321-32 JA |
CANON | VARIOUS MODELS OF X-RAY DIGITAL CAMERA |
| 10 | CANON, INC.-MEDICAL EQUIPMENT GROUP 30-2 SHIMOMARUKO, 3-CHOME OHTA-KU TOKYO, 146-8501 JA 81-3-3758 2111 / 516-328-5602 |
CANON | DIGITAL RADIOGRAPHY SYSTEM |
| 11 | CARESTREAM HEALTH, INC. 1049 WEST RIDGE ROAD ROCHESTER, NY 14615 US / 585-724-5974 |
KODAK DIRECTVIEW CR SYSTEMS AND CR LONG-LENGTH IMAGING SYSTEMS | VARIOUS TYPES OF COMPUTED RADIOGRAPHY SYSTEMS AND ACCESSORIES |
| 12 | CMT MEDICAL TECHNOLOGIES, LTD. HACARMEL STREET, BUILDING 7/2 P.O.B 111 YOQNEAM ILIT, 20692 IS 972-4-8566233 / 972-485-66233 |
SMARTRAD | SOLID STATE X-RAY IMAGER |
| 13 | COREWARE CO. 1667-7, DONGWHA, MUNMAK WONJU-CI, GANGWON-DO, 220-801 KS 82-33-742 0178 / 82-33-742 0178 |
WAVE DR | SOLID STATE RADIOGRAPHY SYSTEM |
| 14 | CR TECH LTD. 5 LAVON ST. HAIFA, 34951 IS 972-482-04667 / 972-4-8204667 |
UCCR 7001/TCCR 7001 | COMPUTED RADIOGRAPHY SYSTEM |
| 15 | DIRECT RADIOGRAPHY CORP. 600 TECHNOLOGY DR. NEWARK, DE 19702 US 781-999-7300 / 781-999-7368 |
DIGITAL IMAGE CAPTURE DEVICE | DIRECTRAY |
| 16 | DRTECH CORP. 333-1, SANGDEAWON 1-DONG JUNGWON-GU SEONGNAM-SHI, GYEONGGI-DO, 462-807 KS 82-31-7306800 / 82-31-730 6800 |
FDXD-1417 | DIGITAL X-RAY DETECTOR |
| 17 | FUJIFILM CORPORATION 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA, 258-8538 JA 813-340-62473 / 203-324-2000 3664 |
MULTIPLE | COMPUTED RADIOGRAPY IMAGE READER |
| 18 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. STAMFORD, CT 06902 US 813-340-62473 / 203-324-2000 3664 |
MULTIPLE | VARIOUS |
| 19 | FUJIFILM TECHNO PRODUCTS CO., LTD. 2-1-3 KITAYUGUCHI HANAMAKI-SHI IWATE, 025-0301 JA 813-340-62473 / 203-324-2000 3664 |
MULTIPLE | COMPUTED RADIOGRAPY IMAGE READER |
| 20 | GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE BP 34 BUC CEDEX, 78533 FR 847-277-5002 / 262-544-3894 |
MULTIPLE | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
| 21 | 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 |
| 22 | IMAGING DYNAMICS COMPANY LTD. 151,2340 PEGASUS WAY, NE CALGARY, ALBERTA, T2E 8M5 CA 403-251-9939 / 403-251-9939 x293 |
XPLORER, XAMINER | DIGITAL RADIOGRAPHIC DETECTORS AND SYSTEMS |
| 23 | INFIMED, INC. 121 METROPOLITAN DR. LIVERPOOL, NY 13088 US 315-453-4545 / 315-453-4545 323 |
STINGRAY DR | SOLID STATE RADIOGRAPHY SYSTEM |
| 24 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. NO. 1 SAKURA-MACHI, HINO-SHI TOKYO, 191-8511 JA 81-42-5891500 / 81-426-609607 |
MULTIPLE | VARIOUS TYPES OF COMPUTED RADIOGRAPHY SYSTEMS & ACCESSORIES |
| 25 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-MACHI, HACHIOJI-SHI TOKYO, 192-8505 JA 81-42-5891500 / 81-426-609607 |
MULTIPLE | VARIOUS TYPES OF COMPUTED RADIOGRAPHY AND ACCESSORIES |
| 26 | KONICA MINOLTA TECHNOPRODUCT CO., LTD. 2-2-1 HIROSEDAI SAYAMA-SHI; SAITAMA-KEN, 350-1328 JA 81-42-5891500 / 81-426-609607 |
MULTIPLE | VARIOUS TYPES OF COMPUTED RADIOGRAPHY SYSTEMS & ACCESSORIES |
| 27 | LAKESHORE TECHNOLOGIES INC. 7536 MURRAY DR. CICERO, NY 13039 US 315-699-2975 / 315-699-2975 |
IMAGE STAR II | DIGITAL IMAGE PROCESSOR |
| 28 | MEDELEX, INC. 1170 MT. VIEW ALVISO RD. SUNNYVALE, CA 94089 US 408-774-0692 / 408-774-0692 |
XSTAR | DIGITAL RADIOGRAPHY SYSTEM |
| 29 | NEW MEDICAL CO., LTD. 4F, NO.42, SINGZHONG RD. NEIHU DISTRICT TAIPEI, 114 TW 886-287-916268 / 886-287-916268 |
SATURN 9000 | SOLID STATE X-RAY IMAGER |
| 30 | NICAL SPA 43 VIA SOFFREDINI MILAN (MI), 20126 IT 39-02-2571110 / 914-275-7679 |
NDR+AND DIVA-D | IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
| 31 | OREX COMPUTED RADIOGRAPHY LTD STAR YOKNEAM BLDG P.O. BOX 505 YOKNEAM, 20692 IS / 972-490-99600 |
PCCR (MULTIPLE MODELS) | ACCESSORY TO ELECTROSTATIC IMAGING SYSTEM |
| 32 | OY AJAT, LTD. TIETOTIE 3 ESPOO, 02150 FI 358-958-400426 / 358-958-400426 |
SCAN300FP/SCAN300FPC | EXTRAORAL IMAGING DEVICE |
| 33 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 BEST, 5684 PC NL 425-487-7000 / 978-659-4663 |
MULTIPLE | X-RAY IMAGER |
| 34 | RADLINK, INC. 2400 MARINE AVE REDONDO BEACH, CA 90278 US 310-643-6900 / 310-643-6900 |
CR-PRO | COMPUTED RADIOGRAPHY |
| 35 | RAYCO (SHANGHAI) MEDICAL PRODUCTS CO., LTD. BLDG 7, 1510 CHUANQIAO RD JINQIAO EXPORT PROCESSING ZONE SHANGHAI, PUDONG NEW AREA, 201206 CH / 585-724-5974 |
MULTIPLE | VARIOUS TYPES OF COMPUTED RADIOGRAPHY SYSTEMS AND ACCESSORIES |
| 36 | RF SYSTEM LAB. 3 NAKAGOSHO NAGANO-SHI, NAGNO, 380-0935 JA 81-26-2257744 / 81-26-2257744 |
RF SYSTEM LAB. | DIGITAL RADIOGRAPHY SYSTEM |
| 37 | SANMINA SCI ISRAEL MEDICAL SYSTEMS LTD. ZONE 5-KOREN INDUSTRIAL PARK MAALOT, 24952 IS / 972-4-9079337 |
PCCR DIGITAL IMAGING DEVICE | X-RAY IMAGER |
| 38 | SCHICK TECHNOLOGIES, INC. 30-30 47TH AVE., SUITE 500 LONG ISLAND CITY, NY 11101 US 718-937-5765 / 718-937-5765 2105 |
CDRW WIRELESS CDR WIRELESS COMPUTED DENTAL RADIOGRAPHY | DIGITAL DENTAL X-RAY SYSTEM |
| 39 | SIEMENS AG, MEDICAL SOLUTIONS SIEMENSSTRASSE 1 FORCHHEIM, 91301 GM / 610-448-4153 |
MULTIPLE | VARIOUS TYPES OF SOLID STATE X-RAY IMAGER |
| 40 | SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. 278 ZHOU ZHU RD SHANGHAI, 201318 CH / 610-448-4153 |
MULTIPLE | SOLID STATE X-RAY IMAGER |
| 41 | SOREDEX PALODEX GROUP OY NAHKELANTIE 160 TUUSULA, FIN-04300 FI 358-45-78822000 / 358-45-78822204 |
MULTIPLE | IMAGING PLATE READERS |
| 42 | TAKARA-BELMONT CO., LTD. 1-1-2 CHOME, HIGASHI-SHINSAIBASHI, CHUO-KU OSAKA, 542 JA 81-662-135945 / 732-469-5000 46 |
ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS | ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS |
| 43 | VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH TAFERNSTRASSE 7 BADEN, DATTWIL, CH-5405 SZ 650-493-4000 / 650-424-5731 |
MULTIPLE | VARIOUS FLAT PANEL DIGITAL IMAGERS |
| 44 | VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS 1678 SOUTH PIONEER ROAD SALT LAKE CITY, UT 84104 US 650-493-4000 / 650-424-5731 |
MULTIPLE | VARIOUS FLAT PANEL DIGITAL IMAGERS |
| 45 | VIDAR SYSTEMS CORP. 365 HERNDON PARKWAY HERNDON, VA 20170 US 703-471-7070 / 703-471-7070 |
VIDAR VISION 3000/4000 | DIGITAL RADIOGRAPHY SYSTEM |
| 46 | VIRTUAL IMAGING, INC. 720 S. POWERLINE RD., STE. E DEERFIELD BEACH, FL 33442 US 954-428-6191 / 954-428-6191 |
FLUOROPRO | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
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