FDA 510(k) Applications for Medical Device:
Camera, Multi Format, Radiological
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K032635 | AGFA CORP. |
10 SOUTH ACADEMY ST. | GREENVILLE | SC | 29601 |
| K023287 | AGFA CORP. |
10 SOUTH ACADEMY ST. | GREENVILLE | SC | 29601 |
| K012941 | AGFA CORP. |
12300 TWINBROOK PKWY,STE 625 | ROCKVILLE | MD | 20852 |
| K022658 | AGFA CORP. |
10 SOUTH ACADEMY ST. | GREENVILLE | SC | 29601 |
| K012010 | AGFA CORP. |
12300 TWINBROOK PKWY,STE 625 | ROCKVILLE | MD | 20852 |
| K052251 | AGFA CORPORATION |
10 SOUTH ACADEMY STREET | GREENVILLE | SC | 29602-9048 |
| K072680 | AGFA HEALTHCARE CORPORATION |
10 SOUTH ACADEMY ST. | GREENVILLE | SC | 29601 |
| K010275 | AGFA MEDICAL IMAGING |
12300 TWINBROOK PKWY, STE 625 | ROCKVILLE | MD | 20852 |
| K962051 | ASPECT ELECTRONICS, INC. |
16303 PANORAMIC WAY | SAN LEANDRO | CA | 94578-1116 |
| K964414 | BAYER CORP., AGFA DIV. |
100 CHALLENGER RD. | RIDGEFIELD PARK | NJ | 07660 |
| K090469 | CARESTREAM HEALTH, INC. |
1 IMATION WAY | OAKDALE | MN | 55128-3414 |
| K111566 | CARESTREAM HEALTH,INC. |
150 VERONA STREET | ROCHESTER | NY | 14608 |
| K030690 | CODONICS, INC. |
17991 ENGLEWOOD DR. | MIDDLEBURG HEIGHTS | OH | 44130 |
| K021054 | CODONICS, INC. |
17991 ENGLEWOOD DR. | MIDDLEBURG HEIGHTS | OH | 44130 |
| K060440 | CODONICS, INC. |
17991 ENGLEWOOD DR. | MIDDLEBURG HEIGHTS | OH | 44130 |
| K962364 | CODONICS, INC. |
17991 ENGLEWOOD DR. | MIDDLEBURG HEIGHTS | OH | 44130 |
| K003481 | CODONICS, INC. |
16303 PANORAMIC WAY | SAN LEANDRO | CA | 94578 |
| K042232 | CODONICS, INC. |
17991 ENGLEWOOD DR. | MIDDLEBURG HEIGHTS | OH | 44130 |
| K973422 | DEJARNETTE RESEARCH SYSTEMS |
401 WASHINGTON AVE. | TOWSON | MD | 21204 |
| K042159 | EASTMAN KODAK COMPANY |
1 IMATION WAY | OAKDALE | MN | 55128-3414 |
| K983905 | EASTMAN KODAK COMPANY |
901 ELMGROVE RD. | ROCHESTER | NY | 14653-0002 |
| K972847 | EASTMAN KODAK COMPANY |
901 ELMGROVE RD. | ROCHESTER | NY | 14653-0002 |
| K002146 | EASTMAN KODAK COMPANY |
1 IMATION PL. | OAKDALE | MN | 55128-3414 |
| K033821 | EASTMAN KODAK COMPANY |
1 IMATION WAY | OAKDALE | MN | 55128-3414 |
| K042158 | EASTMAN KODAK COMPANY |
1 IMATION WAY | OAKDALE | MN | 55128-3414 |
| K011617 | FERRANIA S.P.A. STABILIMENTO DI FERRANIA |
57 VIALE DELLA LIBERTA | FERRANIA, SAVONA | 17014 | |
| K962967 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
333 LUDLOW ST. | STAMFORD | CT | 06912-0035 |
| K033377 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
419 WEST AVE. | STAMFORD | CT | 06902 |
| K972163 | IMATION CORP. |
1 IMATION PLACE | OAKDALE | MN | 55128 |
| K972822 | IMATION ENTERPRISES CORP. |
3M CENTER, BLDG. 235-2B-23 | ST. PAUL | MN | 55144-1000 |
| K953165 | INTERNATIONAL IMAGING ELECTRONICS |
881 REMINGTON BLVD. | BOLINGBROOK | IL | 60440-4932 |
| K992586 | KONICA CORP. |
319 AKENO, OBATA-CHO | MIE-KEN | 5190501 | |
| K032681 | KONICA MEDICAL AND GRAPHIC CORPORATION |
319 AKENO, OBATA-CHO | MIE-KEN | ||
| K061999 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
2970 ISHIKAWA-MACHI | HACHIOJI-SHI, TOKYO | 192-8505 | |
| K042133 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
PROGRESS SECTION | WATARAI-GUN; MIE-KEN | 519-05 | |
| K013052 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
2970 ISHIKAWA-CHO | HACHIOJI-SHI TOKYO | 192-8505 | |
| K081637 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
140 EAST 45TH ST., 25TH FLOOR | NEW YORK | NY | 10017 |
| K061302 | MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS |
319 AKENO, OBATA-CHO | ISE-SHI | MIE-KEN | |
| K011949 | NISHIMOTO SANGYO CO., LTD. |
16303 PANORAMIC WAY | SAN LEANDRO | CA | 94578-1116 |
| K991282 | SEIKO INSTRUMENTS USA, INC. |
2001 EAST OAKSHORES DR. | CROSSROADS | TX | 76227 |
| K971760 | SEIKO INSTRUMENTS USA, INC. |
1-8 NAKASE,MIHAMA-KU,CHIBA-SHI | CHIBA-KEN | 271 | |
| K955394 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH | ISELIN | NJ | 08830 |
| K141454 | SONY ELECTRONICS, INC. |
62 FOREST ST. STE 300 | MARLBOROUGH | MA | 01752 |
| K141346 | SONY ELECTRONICS, INC. |
62 FOREST ST. STE 300 | MARLBOROUGH | MA | 01752 |
| K083522 | SONY ELECTRONICS, INC. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K024188 | SONY MEDICAL SYSTEMS |
C/O MEDICAL DEVICE CONSULT,INC | NORTH ATTLEBORO | MA | 02760 |
| K973028 | STERLING DIAGNOSTIC IMAGING, INC. |
10 SOUTH ACADEMY ST. | GREENVILLE | SC | 29601 |
| K972660 | STERLING DIAGNOSTIC IMAGING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K092280 | VIRTUAL IMAGING, INC. |
333 MILFORD RD. | DEERFIELD | IL | 60015 |
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