FDA 510(k) Applications for Medical Device:
System, Imaging, Optical Coherence Tomography (Oct)
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K232386 |
Abbott Medical |
4 Robbins Road
| Westford |
MA |
01886 |
K210458 |
Abbott Medical |
4 Robbins Road
| Westford |
MA |
01886 |
K132800 |
AGFA HEALTHCARE N.V. |
10 SOUTH ACADEMY STREET
| GREENVILLE |
SC |
29601 |
K201552 |
Apollo Medical Optics, Ltd. |
2F., No.43, Ln. 188, Ruiguang Rd., Neihu Dist.
| Taipei City |
|
114 |
K133209 |
DIAGNOSTIC PHOTONICS, INC |
1835 MARKET STREET
| PHILADELPHIA |
PA |
19103 |
K192922 |
Gentuity, LLC |
142 North Road, Suite G
| Sudbury |
MA |
01776 |
K033783 |
IMALUX COPORATION |
1771 EAST 30TH ST.
| CLEVELAND |
OH |
44114 |
K042894 |
IMALUX CORPORATION |
1771 EAST 30TH STREET
| CLEVELAND |
OH |
44114 |
K123369 |
LIGHTLAB IMAGING, INC. |
4 ROBBINS ROAD
| WESTFORD |
MA |
01886 |
K150237 |
LIGHTLAB IMAGING, INC. |
4 ROBBINS ROAD
| WESTFORD |
MA |
01886 |
K151286 |
LIGHTLAB IMAGING, INC. |
4 ROBBINS ROAD
| WESTFORD |
MA |
01886 |
K160878 |
LIGHTLAB IMAGING, INC. |
4 ROBBINS ROAD
| WESTFORD |
MA |
01866 |
K152120 |
LIGHTLAB IMAGING, INC. |
4 ROBBINS ROAD
| WESTFORD |
MA |
01866 |
K111201 |
LIGHTLAB IMAGING,INC. |
ONE TECHNOLOGY PARK DRIVE
| WESTFORD |
MA |
01886 |
K093857 |
LIGHTLAB IMAGING,INC. |
7 TRAIL HOUSE CT
| ROCKVILLE |
MD |
20850 |
K150878 |
LIGHTLAB IMAGING,INC. |
4 ROBBINS ROAD
| WESTFORD |
MA |
01886 |
K153283 |
Michelson Diagnostics Ltd |
Ground Floor Eclipse House, Eclipse Park, Sittingbourne Road
| Maidstone |
|
me14 3en |
K093520 |
MICHELSON DIAGNOSTICS LTD. |
11A GRAYS FARM PRODUCTION VILL
| ORPINGTON, KENT |
|
BR5 3BD |
K162466 |
MICRO-TECH (NANJING) CO.,LTD. |
NO. 10 GAOKE THIRD ROAD
| NANJING |
|
210032 |
K121195 |
NINEPOINT MEDICAL, INC |
1171 BARROIHET AVENUE
| HILLSBOROUGH |
CA |
94010 |
K112770 |
NINEPOINT MEDICAL, INC |
1171 BARROIHET AVENUE
| HILLSBOROUGH |
CA |
94010 |
K153479 |
NINEPOINT MEDICAL, INC |
12 OAK PARK DRIVE
| BEDFORD |
MA |
01730 |
K191117 |
NinePoint Medical, Inc |
12 Oak Park Drive
| Bedford |
MA |
01730 |
K120800 |
NINEPOINT MEDICAL, INC. |
1171 BARROILHET AVE
| HILLSBOROUGH |
CA |
94010 |
K182261 |
NinePoint Medical, Inc. |
12 Oak Park Drive
| Bedford |
MA |
01730 |
K143678 |
NINEPOINT MEDICAL, INC. |
ONE KENDALL SQUARE, SUITE B7501
| CAMBRIDGE |
MA |
02139 |
K182616 |
NinePoint Medical, Inc. |
12 Oak Park Drive
| Bedford |
MA |
01730 |
K203578 |
Perimeter Medical Imaging AI, Inc. |
359 Eastern Avenue, Suite 110
| Toronto |
|
M4M 1B7 |
K190404 |
Perimeter Medical Imaging, Inc. |
1 Yonge Street, Suite 201
| Toronto |
|
M5E !E6 |
K171560 |
Perimeter Medical Imaging, Inc. |
47 Colborne Street
| Toronto |
|
M5E 1P8 |
K160240 |
PERIMETER MEDICAL IMAGING, INC. |
156 FRONT STREET WEST, SUITE 501
| TORONTO |
|
M5J 2L6 |
K230691 |
SpectraWAVE Inc |
12 Oak Park Drive
| Bedford |
MA |
01730 |
K221257 |
SpectraWAVE Inc |
12 Oak Park Drive
| Bedford |
MA |
01730 |
K183320 |
St. Jude Medical (now Abbott Medical) |
One St. Jude Medical Drive
| St. Paul |
MN |
55117 |
K102599 |
TOMOPHASE CORPORATION |
14 BURGUNDY DRIVE
| HAMPTON |
NH |
03842 |
|
|