FDA 510(k) Applications for Medical Device:
System, Simulation, Radiation Therapy
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K101038 |
ACCELETRONICS DIGITAL IMAGING, LLC. |
602 GORDON DR
| EXTON |
PA |
19341 |
K052345 |
GE HEALTHCARE |
3000 N. GRANDVIEW BLVD
| WAUKESHA |
WI |
53188 |
K132944 |
GE HUNGARY KFT |
DBA GE HEALTHCARE
| WAUKESHA |
WI |
53188 |
K132045 |
GE HUNGARY KFT |
3000 N GRANDVIEW
| WAUKESHA |
WI |
53188 |
K021780 |
GENERAL ELECTRIC MEDICAL SYSTEMS |
3000 NORTH GRANDVIEW BLVD.
| WAUKESHA |
WI |
53188 |
K982857 |
HELAX AB |
KLOSTERGATAN 10-12
| UPPSALA |
|
|
K964972 |
I.Z.I. MEDICAL PRODUCTS CORP. |
10 STREAM COURT
| OWINGS MILLS |
MD |
21117 |
K061006 |
IKOETECH, LLC. |
3000 RICHMOND, SUITE 200
| HOUSTON |
TX |
77098 |
K083591 |
IKOETECH, LLC. |
6223 RICHMOND AVE., SUITE 303
| HOUSTON |
TX |
77057 |
K013531 |
IMPAC MEDICAL SYSTEMS, INC. |
100 WEST EVELYN AVE.
| MOUNTAIN VIEW |
CA |
94041 |
K022219 |
MEDCOM GMBH |
RUNDETURMSTR. 12
| DARMSTADT, HESSEN |
|
64283 |
K032550 |
MEDCOM GMBH |
RUNDETURMSTR. 12
| DARMSTADT, HESSEN |
|
64283 |
K973848 |
NUCLETRON CORP. |
7080 COLUMBIA GATEWAY DR.
| COLUMBIA |
MD |
21046 |
K072445 |
NUCLETRON CORP. |
8671 ROBERT FULTON DRIVE
| COLUMBIA |
MD |
21046 |
K090706 |
NUCLETRON CORPORATION |
8671 ROBERT FULTON DR.
| COLUMBIA |
MD |
21046 |
K033470 |
NUCLETRON CORPORATION |
8671 ROBERT FULTON DR.
| COLUMBIA |
MD |
21046-2133 |
K052361 |
NUCLETRON CORPORATION |
8671 ROBERT FULTON DR.
| COLUMBIA |
MD |
21046-2133 |
K953233 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
4040 NELSON AVE.
| CONCORD |
CA |
94520 |
K960737 |
SYSTEMS SUPPLY SERVICES, INC. |
P.O. BOX 786
| URBANNA |
VA |
23175-0786 |
K992751 |
VARIAN ASSOC., INC. |
3045 HANOVER ST.
| PALO ALTO |
CA |
94304-1129 |
K023052 |
VARIAN MEDICAL SYSTEMS, INC. |
3100 HANSEN WAY
| PALO ALTO |
CA |
94304 |
K033339 |
VARIAN MEDICAL SYSTEMS, INC. |
3100 HANSEN WAY
| PALO ALTO |
CA |
94304-1038 |
K971839 |
VARIAN MEDICAL SYSTEMS, INC. |
3045 HANOVER ST.
| PALO ALTO |
CA |
94304-1120 |
K964138 |
VARIAN MEDICAL SYSTEMS, INC. |
GATWICK ROAD
| CRAWLEY, WEST SUSSEX |
|
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