FDA 510(k) Applications for Medical Device:
Full Field Digital,System,X-Ray,Mammographic

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K172027 ADANI Selitski St., 7
Minsk 220075
K111324 AGFA HEALTHCARE N.V. 10 S ACADEMY STREET
GREENVILLE SC 29601
K120246 CARESTREAM HEALTH,INC. 150 VERONA STREET
ROCHESTER NY 14608
K162670 DRTECH CORPORATION SUITE NO.2, 3 FLOOR, 29, DUNCHON-DAERO541BEON-GIL,
SEONGNAM-SI 13230
K170930 DRTECH Corporation Suit No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil
Seongnam-si 13230
K111646 FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE.
STAMFORD CT 06902-6300
K121674 FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE.
STAMFORD CT 06902-6300
K173132 Fujifilm Medical Systems U.S.A., Inc. 419 West Avenue
Stamford CT 06902
K133972 FUJIFILM MEDICAL SYSTEMS, USA INC. 419 WEST AVE.
STANFORD CT 06902
K110729 FUJIFILM MEDICAL SYSTEMS, USA INC. 419 WEST AVENUE
STAMFORD CT 06902
K173576 GE Healthcare 283 rue de la Miniere
Buc 78530
K182951 GE Healthcare 28 rue de la Miniere
Buc 78530
K190809 GE Healthcare 283 rue de la Miniere
Buc 78530
K172404 GE Healthcare 283 rue de la Miniere
Buc 78530
K162268 GE HEALTHCARE 283 RUE DE LA MINIERE
BUC 78530
K163302 GE Healthcare 283 rue de la Miniere
Buc 78530
K131885 GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE
BUC 78530
K103485 GENERAL ELECTRIC COMPANY 3000 N. GRANDVIEW BLVD., W-709
WAUKESHA WI 53188
K110798 GENERAL ELECTRIC COMPANY 3000 NORTH GRANDVIEW BLVD.
WAUKESHA WI 53188
K111434 GIOTTO USA, LLC 9001 Wesleyan Road
Indianapolis IN 46268
K123873 HOLOGIC, INC. 35 CROSBY DR.
BEDFORD MA 01730
K122510 ICRCO INC. 2580 WEST 237TH STREET
TORRANCE CA 90505
K110717 KONICA MINOLTA MEDICAL & GRAPHIC, INC. 25 WALNUT STREET
MONROE CT 06468
K123995 PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB Smidesvagen 5
Solna SE-171 41
K130704 PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB Smidesvagen 5
Solna SE-171 41
K120255 PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB Smidesvagen 5
Solna SE-171 41
K110572 PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD.
ANDOVER MA 01810-1099
K111361 PLANMECA USA, INC. 100 N. GARY AVE. SUITE A
ROSELLE IL 60172
K163328 Planmed Oy Sorvaajankatu 7
Helsinki FI-00880
K121963 PLANMED OY ASENTAJANKATU 6
HELSINKI FI-00880
K110025 SECTRA IMTEC AB TEKNIKEINGEN 20
LINKOPING 58330
K163252 SIEMENS MEDICAL SOLUTIONS USA, INC 40 Liberty Boulevard, Mail Code 65-1A
Malvern PA 19355
K122286 SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY.
MALVERN PA 19355-1406
K151645 Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway
Malvern PA 19355
K123520 SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY.
MALVERN PA 19355-1406
K173408 Siemens Medical Solutions, Inc. 40 Liberty Boulevard 65-1A
Malvern PA 19355




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