Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K170981 |
Device Name |
NeuroQuant |
Applicant |
CorTechs Labs, Inc |
4690 Executive Drive, Suite 250 |
San Diego,
CA
92121
|
|
Applicant Contact |
Kora Marinkovic |
Correspondent |
CorTechs Labs, Inc |
4690 Executive Drive, Suite 250 |
San Diego,
CA
92121
|
|
Correspondent Contact |
Kora Marinkovic |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/03/2017 |
Decision Date | 09/07/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|