FDA 510(k) Applications for Medical Device:
Device, Digital Image Storage, Radiological
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K960941 | BASE TEN SYSTEMS, INC. |
ONE ELECTRONICS DR. | TRENTON | NJ | 08619 |
| K961160 | BASE TEN SYSTEMS, INC. |
ONE ELECTTONICS DR. | TRENTON | NJ | 08619 |
| K963936 | BIOSOUND, INC. |
8000 CASTLEWAY DR. | INDIANAPOLIS | IN | 46250 |
| K964274 | COMVIEW CORP. |
31 ALBANY POST RD. | MONTROSE | NY | 10548 |
| K955184 | E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC |
625 ALASKA AVE. | TORRANCE | CA | 90503-5124 |
| K972380 | EASTMAN KODAK COMPANY |
18325 WATERVIEW PKWY. | DALLAS | TX | 75252 |
| K960326 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
333 LUDLOW ST. | STAMFORD | CT | 06912-0035 |
| K973413 | I.S.G. TECHNOLOGIES, INC. |
6509 AIRPORT ROAD | MISSISSAUGA, ONTARIO | L4V 1S7 | |
| K952238 | IMAGING CONCEPTS, INC. |
8010 STAPLES MILL RD. | RICHMOND | VA | 23228 |
| K951942 | INSIGHT SYSTEMS |
14 SUNSET RIDGE DR. | POMONA | CA | 91766 |
| K984405 | INTRACOM CORP. |
1309 S. MARY AVE. | SUNNYVALE | CA | 94087 |
| K960981 | KODAK HEALTH IMAGING SYSTEMS, INC. |
18325 WATERVIEW PKWY. | DALLAS | TX | 75252 |
| K964803 | NETWORK CONCEPTS, INC. |
2135 W. GREENVIEW DR. | MIDDLETON | WI | 53562 |
| K973463 | OTECH, INC. |
6741 GRANT LN. | PLANO | TX | 75024 |
| K971451 | OTECH, INC. |
6741 GRANT LN. | PLANO | TX | 75024 |
| K980243 | PARAMETER DEVELOPMENTS, INC. |
16303 PANORAMIC WAY | SAN LEANDRO | CA | 94578-1116 |
| K992131 | SAMSUNG SDS CO., LTD |
2001 EAST OAKSHORES DR. | AUBREY | TX | 76227 |
| K963395 | SECTRA-IMTEC AB |
6741 GRANT LN. | PLANO | TX | 75024 |
| K983447 | SECTRA-IMTEC AB |
6741 GRANT LN. | PLANO | TX | 75024 |
| K961680 | SONY MEDICAL SYSTEMS |
C/O MEDICAL DEVICE CONSULT,INC | NORTH ATTLEBORO | MA | 02760 |
| K955237 | TAU CORP. |
983 UNIVERSITY AVE. | LOS GATOS | CA | 95030-2305 |
| K971848 | TDK ELECTRONICS CORPORATION OF AMERICA |
12 HARBOR PARK DR. | PORT WASHINGTON | NY | 11050 |
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