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 | |
| K240610 | DAMAE Medical |
14 Rue Sthrau | Paris | 75013 | |
| K133209 | DIAGNOSTIC PHOTONICS, INC |
1835 MARKET STREET | PHILADELPHIA | PA | 19103 |
| K192922 | Gentuity, LLC |
142 North Road, Suite G | Sudbury | MA | 01776 |
| K242239 | 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 |
| K242924 | OPXION Technology Inc. |
| New Taipei City | 251401 | |
| 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 | |
| K242098 | Shenzhen Vivolight Medical Device & Technology Co., Ltd. |
Room 511-A, 5th Floor, Block B, Building R2, High-Tech Indus | Shenzhen | 518055 | |
| K230691 | SpectraWAVE Inc |
12 Oak Park Drive | Bedford | MA | 01730 |
| K221257 | SpectraWAVE Inc |
12 Oak Park Drive | Bedford | MA | 01730 |
| K251198 | SpectraWAVE, Inc. |
12 Oak Park Drive | Bedford | MA | 01730 |
| K243016 | SpectraWAVE, Inc. |
12 Oak Park Dr. | Bedford | MA | 01730 |
| K183320 | St. Jude Medical (now Abbott Medical) |
One St. Jude Medical Drive | St. Paul | MN | 55117 |
| K250684 | Terumo Cardiovascular Systems THI Plant |
6190 Jackson Rd | Ann Arbor | MI | 48103 |
| K102599 | TOMOPHASE CORPORATION |
14 BURGUNDY DRIVE | HAMPTON | NH | 03842 |
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