FDA 510(k) Applications for Medical Device:
System, Simulation, Radiation Therapy

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K101038 ACCELETRONICS DIGITAL IMAGING, LLC. 602 GORDON DR
EXTON PA 19341
K052345 GE HEALTHCARE 3000 N. GRANDVIEW BLVD
WAUKESHA WI 53188
K132944 GE HUNGARY KFT DBA GE HEALTHCARE
WAUKESHA WI 53188
K132045 GE HUNGARY KFT 3000 N GRANDVIEW
WAUKESHA WI 53188
K021780 GENERAL ELECTRIC MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD.
WAUKESHA WI 53188
K982857 HELAX AB KLOSTERGATAN 10-12
UPPSALA
K964972 I.Z.I. MEDICAL PRODUCTS CORP. 10 STREAM COURT
OWINGS MILLS MD 21117
K061006 IKOETECH, LLC. 3000 RICHMOND, SUITE 200
HOUSTON TX 77098
K083591 IKOETECH, LLC. 6223 RICHMOND AVE., SUITE 303
HOUSTON TX 77057
K013531 IMPAC MEDICAL SYSTEMS, INC. 100 WEST EVELYN AVE.
MOUNTAIN VIEW CA 94041
K022219 MEDCOM GMBH RUNDETURMSTR. 12
DARMSTADT, HESSEN 64283
K032550 MEDCOM GMBH RUNDETURMSTR. 12
DARMSTADT, HESSEN 64283
K973848 NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR.
COLUMBIA MD 21046
K072445 NUCLETRON CORP. 8671 ROBERT FULTON DRIVE
COLUMBIA MD 21046
K090706 NUCLETRON CORPORATION 8671 ROBERT FULTON DR.
COLUMBIA MD 21046
K033470 NUCLETRON CORPORATION 8671 ROBERT FULTON DR.
COLUMBIA MD 21046-2133
K052361 NUCLETRON CORPORATION 8671 ROBERT FULTON DR.
COLUMBIA MD 21046-2133
K953233 SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE.
CONCORD CA 94520
K960737 SYSTEMS SUPPLY SERVICES, INC. P.O. BOX 786
URBANNA VA 23175-0786
K992751 VARIAN ASSOC., INC. 3045 HANOVER ST.
PALO ALTO CA 94304-1129
K023052 VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY
PALO ALTO CA 94304
K033339 VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY
PALO ALTO CA 94304-1038
K971839 VARIAN MEDICAL SYSTEMS, INC. 3045 HANOVER ST.
PALO ALTO CA 94304-1120
K964138 VARIAN MEDICAL SYSTEMS, INC. GATWICK ROAD
CRAWLEY, WEST SUSSEX




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