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 | |
| K193334 | GE Healthcare |
283 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 |
| K200424 | IMS GIOTTO S.p.A. |
Via Sagittario 5 | Sasso Marconi | 40037 | |
| 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 |
| K193166 | Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard, 65-1A | Malvern | PA | 19355 |
| K173408 | Siemens Medical Solutions, Inc. |
40 Liberty Boulevard 65-1A | Malvern | PA | 19355 |
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