Device Classification Name |
System, Imaging, Optical Coherence Tomography (Oct)
|
510(k) Number |
K171560 |
Device Name |
OTIS Optical Coherence Tomography System |
Applicant |
Perimeter Medical Imaging, Inc. |
47 Colborne Street |
Suite 202 |
Toronto,
CA
M5E 1P8
|
|
Applicant Contact |
Elizabeth Munro |
Correspondent |
Perimeter Medical Imaging, Inc. |
47 Colborne Street |
Suite 202 |
Toronto,
CA
M5E 1P8
|
|
Correspondent Contact |
Elizabeth Munro |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 05/30/2017 |
Decision Date | 08/25/2017 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|