FDA 510(k) Applications for Medical Device:
Digitizer, Image, Radiological
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K974619 | AFP IMAGING CORP. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K982785 | ARRAY CORP. |
3-42-10 YOYOGI, SHIBUYA-KU | TOKYO | 151-0053 | |
| K063424 | ARRAY CORP. |
3-42-10 YOYOGI, SHIBUYA-KU | TOKYO | 151-0053 | |
| K033637 | ARRAY CORP. |
3-42-10 YOYOGI | SHIBUYA-KU, TOKYO | 151-0053 | |
| K954875 | ASPECT ELECTRONICS, INC. |
16303 PANORAMIC WAY | SAN LEANDRO | CA | 94578-1116 |
| K132183 | BAR CODE COMPUTER LTD |
6 SIRENI | HAIFA | 32972 | |
| K990066 | CAMTRONICS, LTD. |
MEDICAL SYSTEMS | HARTLAND | WI | 53029 |
| K960839 | CANNON U.S.A., INC. |
ONE CANNON PLAZA | LAKE SUCCESS | NY | 11042 |
| K992467 | DBA SYSTEMS, INC. |
555 13TH STREET, N.W. | WASHINGTON | DC | 20004 |
| K971894 | EASTMAN KODAK COMPANY |
343 STATE ST. | ROCHESTER | NY | 14650-1131 |
| K013631 | EFILM MEDICAL, INC. |
500 UNIVERSITY AVE., SUITE 300 | TORONTO, ONTARIO | M5G 1V7 | |
| K020243 | ERADLINK, INC. |
19529 CHAPARRAL CIR. | PENN VALLEY | CA | 95946-9443 |
| K013395 | FERRANIA S.P.A. |
57 VIALE DELLA LIBERTA | FERRANIA, SAVONA | 17014 | |
| K973411 | GENERAL SCANNING, INC. |
500 ARSENAL ST. | WATERTOWN | MA | 02172 |
| K980565 | GENERAL SCANNING, INC. |
500 ARSENAL ST. | WATERTOWN | MA | 02172 |
| K021949 | HOWTEK, INC. |
21 PARK AVE. | HUDSON | NH | 03051 |
| K970908 | HOWTEK, INC. |
21 PARK AVE. | HUDSON | NH | 03051 |
| K953117 | HOWTEK, INC. |
21 PARK AVE. | HUDSON | NH | 03051 |
| K984252 | IMATION CORP. |
1 IMATION PLACE | OAKDALE | MN | 55128 |
| K961768 | KODAK HEALTH IMAGING SYSTEMS, INC. |
18325 WATERVIEW PKWY. | DALLAS | TX | 75252 |
| K980873 | KONICA CORP. |
THE CHRYSLER BUILDING | NEW YORK | NY | 10174 |
| K980213 | LUMISYS, INC. |
1350 NORTH KOLB RD. | TUCSON | AZ | 85715 |
| K980809 | LUMISYS, INC. |
16303 PANORAMIC WAY | SAN LEANDRO | CA | 94578 |
| K091288 | MICROTEK INTERNATIONAL, INC. |
NO. 8, LANE 29 WENMING ROAD | GUISAN, TAOYUAN | 33383 | |
| K042484 | NAI TECHNOLOGY PRODUCTS |
1342-D NORTH BENSON AVENUE | UPLAND | CA | 91786 |
| K984409 | NISHIMOTO SANGYO CO., LTD. |
16303 PANORAMIC WAY | SAN LEANDRO | CA | 94578-1116 |
| K964288 | PC TELERADIOLOGY |
3519 E. ARCATA RD. | SALT LAKE CITY | UT | 84124 |
| K032022 | PYRAMID MEDICAL, INC. |
10940 PORTAL MEDICAL DR. | LOS ALAMITOS | CA | 90720 |
| K022810 | RADIOGRAPHIC DIGITAL IMAGING, INC. |
20406 EARL ST. | TORRANCE | CA | 90503 |
| K000411 | STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK |
24 EASTMAN AVE. C5 | BEDFORD | NH | 03110 |
| K001841 | TAGARNO A/S |
HATTINGVEJ 5 | HORSENS | 8700 | |
| K993599 | VIDAR SYSTEMS CORP. |
460 SPRING PARK PL. | HERNDON | VA | 20170 |
| K130406 | VIDAR SYSTEMS CORP. |
365 Herndon Pkwy | HERNDON | VA | 20170 |
| K011049 | VIDAR SYSTEMS CORP. |
460 SPRING PARK PL. | HERNDON | VA | 20170 |
| K993598 | VIDAR SYSTEMS CORP. |
460 SPRING PARK PL. | HERNDON | VA | 20170 |
| K993597 | VIDAR SYSTEMS CORP. |
460 SPRING PARK PL. | HERNDON | VA | 20170 |
| K102476 | VIDAR SYSTEMS CORP. |
365 HERNDON PARKWAY | HERNDON | VA | 20170 |
| K130636 | VIDAR SYSTEMS CORP. |
365 Herndon Pkwy | HERNDON | VA | 20170 |
| K093809 | VIDAR SYSTEMS CORP. |
365 HERNDON PARKWAY | HERNDON | VA | 20170 |
| K974315 | VIDAR SYSTEMS CORP. |
460 SPRING PARK PL. | HERNDON | VA | 20170 |
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