Device Classification Name |
Radiological Computer-Assisted Prioritization Software For Lesions
|
510(k) Number |
K223443 |
Device Name |
Viz AAA |
Applicant |
Viz. ai, Inc. |
201 Mission St., 12th Floor |
San Francisco,
CA
94105
|
|
Applicant Contact |
Pooja Shah |
Correspondent |
Viz. ai, Inc. |
201 Mission St., 12th Floor |
San Francisco,
CA
94105
|
|
Correspondent Contact |
Pooja Shah |
Regulation Number | 892.2080
|
Classification Product Code |
|
Date Received | 11/14/2022 |
Decision Date | 03/17/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|