FDA 510(k) Applications for Medical Device:
System, X-Ray, Mammographic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K023229 | AMERICAN MAMMOGRAPHICS, INC. |
1302 SHAWHAN TERRACE | CHATTANOOGA | TN | 37411 |
| K073262 | BEEKLEY CORP. |
150 DOLPHIN RD. | BRISTOL | CT | 06011 |
| K020624 | BEEKLEY CORP. |
PRESTIGE LN. | BRISTOL | CT | 06010 |
| K964576 | BENNETT X-RAY CORP. |
445 OAK ST. | COPIAGUE | NY | 11726 |
| K003795 | BIOLUCENT, INC. |
27121 ALISO CREEK RD. | ALISO VIEJO | CA | 92656 |
| K992037 | DEL MEDICAL IMAGING CORP. |
11550 WEST KING ST. | FRANKLIN PARK | IL | 60131 |
| K993681 | DIGITEC MEDICAL SERVICE CORP. |
465 MALTBIE ST. | LAWRENCEVILLE | GA | 30045 |
| K010792 | DIGITEC MEDICAL SERVICE CORP. |
465 MALTBIE ST. | LAWRENCEVILLE | GA | 30045 |
| K071787 | DJA DISTRIBUTORS, LLC |
2225 E. FLAMINGO ROAD | LAS VEGAS | NV | 89119 |
| K983313 | ELSCINT, INC. |
22 PARIS AVE. | ROCKLEIGH | NJ | 07647 |
| K970680 | ELSCINT, INC. |
86 ORCHARD ST. | HACKENSACK | NJ | 07601 |
| K960381 | ELSCINT, INC. |
505 MAIN ST. | HACKENSACK | NJ | 07601 |
| K003473 | ELSCINTEC SYSTEMS LTD. |
MATAM-ADVANCED TECH. CENTER | HAIFA | 31000 | |
| K042095 | FISCHER IMAGING CORP. |
12300 NORTH GRANT ST. | DENVER | CO | 80241-3120 |
| K973400 | FISCHER IMAGING CORP. |
12300 NORTH GRANT ST. | DENVER | CO | 80241-3120 |
| K113284 | FUJI FILM MEDICAL SYSTEMS |
419 WEST AVE. | STAMFORD | CT | 06902 |
| K191495 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | ||
| K953250 | GE MEDICAL SYSTEMS |
P.O. 414 | MILWAUKEE | WI | 53201 |
| K040125 | GE MEDICAL SYSTEMS, INC. |
3000 N. GRANDVIEW BLVD. | WAUKESHA | WI | 53188 |
| K113607 | GIOTTO USA, LLC |
81 SEACOUNTRY LANE | RANCHO SANTA MARGARITA | CA | 92688 |
| K062039 | GIOTTO USA, LLC |
11460 N MERIDIAN ST., STE 150 | CARMEL | IN | 46032 |
| K161575 | HOLOGIC |
36 APPLE RIDGE ROAD | DANBURY | CT | 06810 |
| K153486 | Hologic Inc |
36 Apple Ridge Road | Danbury | CT | 06810 |
| K202294 | Hologic, Inc |
36 Apple Ridge Road | Danbury | CT | 06810 |
| K103512 | HOLOGIC, INC. |
36 APPLE RIDGE ROAD | DANBURY | CT | 06810 |
| K100692 | HOLOGIC, INC. |
36 APPLE RIDGE ROAD | DANBURY | CT | 06810 |
| K040884 | HOLOGIC, INC. |
36 APPLE RIDGE ROAD | DANBURY | CT | 06810 |
| K203509 | IMS Giotto S.p.A. |
VIA Sagittario, 5 | Sasso Marconi | 40037 | |
| K981641 | INSTRUMENTARIUM CORP. |
300 WEST EDGERTON AVE. | MILWAUKEE | WI | 53207 |
| K022275 | INSTRUMENTARIUM CORP. IMAGING DIVISION |
300 WEST EDGERTON AVE. | MILWAUKEE | WI | 53207 |
| K023864 | INSTRUMENTARIUM CORP. IMAGING DIVISION |
300 WEST EDGERTON AVE. | MILWAUKEE | WI | 53207 |
| K955411 | INSTRUMENTARIUM IMAGING, INC. |
P.O. BOX 20 (NAHKELANTIE 160) | TUUSULA, FINLAND | ||
| K001171 | INSTRUMENTARIUM IMAGING, INC. |
300 WEST EDGERTON AVE. | MILWAUKEE | WI | 53207-6025 |
| K002472 | INSTRUMENTARIUM IMAGING, INC. |
300 WEST EDGERTON AVE. | MILWAUKEE | WI | 53207-6025 |
| K000976 | INSTRUMENTARIUM IMAGING, INC. |
300 WEST EDGERTON AVE. | MILWAUKEE | WI | 53207-6025 |
| K101373 | IZI MEDICAL PRODUCTS INC. |
7020 TUDSBURY RD. | BALTIMORE | MD | 21244 |
| K973915 | KCI NEW TECHNOLOGIES, INC. |
3440 EAST HOUSTON | SAN ANTONIO | TX | 78219 |
| K980235 | KCI NEW TECHNOLOGIES, INC. |
P.O. BOX 659508 | SAN ANTONIO | TX | 78265 |
| K070344 | LIV INTERNATIONAL USA, INC. |
5811 PARTRIDGE DRIVE SW | ROCHESTER | MN | 55902 |
| K033202 | LIVINGSTON PRODUCTS, INC. |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K992280 | LORAD CORP. |
36 APPLE RIDGE RD. | DANBURY | CT | 06810 |
| K973631 | LORAD CORP. |
36 APPLE RIDGE RD. | DANBURY | CT | 06810 |
| K122836 | LORAD, A HOLOGIC CO. |
36 APPLE RIDGE RD. | DANBURY | CT | 06810 |
| K071542 | LORAD, A HOLOGIC CO. |
36 APPLE RIDGE RD. | DANBURY | CT | 06810 |
| K013290 | LORAD, A HOLOGIC CO. |
36 APPLE RIDGE RD. | DANBURY | CT | 06810 |
| K011987 | LORAD, A HOLOGIC CO. |
36 APPLE RIDGE RD. | DANBURY | CT | 06810 |
| K030666 | LORAD, A HOLOGIC CO. |
36 APPLE RIDGE RD. | DANBURY | CT | 06810 |
| K123414 | MACBRUD CORP., MEDICAL DIVISION |
14021 SW 143 COURT, UNIT 6 | MIAMI | FL | 33186 |
| K953902 | MEDICAL MARKETING INTL., INC. |
12748 EAST MILLBURN AVE. | BATON ROUGE | LA | 70815 |
| K993740 | MEDICAL SYSTEMS GROUP |
11550 WEST KING ST. | FRANKLIN PARK | IL | 60131 |
| K012953 | MEDX, INC. |
3456 NORTH RIDGE AVE., #100 | ARLINGTON HEIGHTS | IL | 60004 |
| K973493 | PLANMED OY |
362, BALM COURT | WOOD DALE | IL | 60191 |
| K013656 | PLANMED OY |
1250 GREENBRIAR, SUITE A | ADDISON | IL | 60101 |
| K983659 | PLANMED OY |
ASENTAJANKATU 6 | HELSINKI | 00880 | |
| K021945 | PLANMED OY |
100 NORTH GRAY AVE. SUITE A | ROSELLE | IL | 60172 |
| K991826 | PLANMED OY |
362, BALM COURT | WOOD DALE | IL | 60191 |
| K042671 | PLANMED OY |
100 NORTH GRAY AVE. SUITE A | ROSELLE | IL | 60172 |
| K010116 | PLANMED OY |
1250 GREENBRIAR, SUITE A | ADDISON | IL | 60101 |
| K962105 | PLANMED OY |
ASENTAJANKATU 6 | HELSINKI | 00880 | |
| K161920 | PRECISION DYNAMICS CORPORATION |
27770 ENTERTAINMENT DRIVE, STE 200 | VALENCIA | CA | 91355 |
| K983621 | REMINGTON MEDICAL, INC. |
6830 MEADOWRIDGE CT. | ALPHARETTA | GA | 30005 |
| K031574 | S & S X-RAY PRODUCTS, INC. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K961849 | SHAI SYG MOTION AND INNOVATIONS, LTD. |
POB 6718 | EFRAT | 90435 | |
| K964069 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVE. SOUTH | ISELIN | NJ | 08830 |
| K003945 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH | ISELIN | NJ | 08830 |
| K982049 | SITCO, INC. |
3456 N. RIDGE AVE. #100 | ARLINGTON HEIGHTS | IL | 60004 |
| K990192 | SITCO, INC. |
3456 N. RIDGE AVE. #100 | ARLINGTON HEIGHTS | IL | 60004 |
| K973856 | SITCO, INC. |
25663 HILLVIEW CT. | MUNDELEIN | IL | 60060 |
| K050663 | TRAXYZ MEDICAL, INC. |
290 TURNPIKE RD SUITE 6 #323 | WESTBORO | MA | 01581 |
| K984091 | TREX MEDICAL CORP. |
445 OAK ST. | COPIAGUE | NY | 11726-2719 |
| K984092 | TREX MEDICAL CORP. |
445 OAK ST. | COPIAGUE | NY | 11726-2719 |
| K152038 | Women's Imaging Solutions Enterprises LLC |
226 Wilson Drive | Cresskill | NJ | 07626 |
| K981470 | WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
125 MAIN ST., NORTH | WOODBURY | CT | 06798-0505 |
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