Device Classification Name |
Radiological Computer-Assisted Prioritization Software For Lesions
|
510(k) Number |
K213319 |
Device Name |
Viz ANEURYSM, Viz ANX |
Applicant |
Viz.ai, Inc. |
201 Mission St, 12th Floor |
San Francisco,
CA
94105
|
|
Applicant Contact |
Gregory Ramina |
Correspondent |
Viz.ai, Inc. |
201 Mission St, 12th Floor |
San Francisco,
CA
94105
|
|
Correspondent Contact |
Gregory Ramina |
Regulation Number | 892.2080
|
Classification Product Code |
|
Date Received | 10/04/2021 |
Decision Date | 02/18/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|