Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K193319 |
Device Name |
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System |
Applicant |
Vasoptic Medical Inc. |
1215 East Fort Avenue, Suite 304 |
Baltimore,
MD
21230
|
|
Applicant Contact |
Abhishek Rege |
Correspondent |
Vasoptic Medical Inc. |
1215 East Fort Avenue, Suite 304 |
Baltimore,
MD
21230
|
|
Correspondent Contact |
Abhishek Rege |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 12/02/2019 |
Decision Date | 06/01/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|