Device Classification Name |
system, imaging, optical coherence tomography (oct)
|
510(k) Number |
K182261 |
Device Name |
NvisionVLE Imaging System, NvisionVLE Optical Probe |
Applicant |
NinePoint Medical, Inc. |
12 Oak Park Drive |
Bedford,
MA
01730
|
|
Applicant Contact |
Eman Namati |
Correspondent |
NinePoint Medical, Inc. |
12 Oak Park Drive |
Bedford,
MA
01730
|
|
Correspondent Contact |
Eman Namati |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 08/21/2018 |
Decision Date | 10/16/2018 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|