Device Classification Name |
radiological computer-assisted triage and notification software
|
De Novo Number |
DEN170073 |
Device Name |
ContaCT |
Requester |
viz.al, inc. |
343 texas st. |
san francisco,
CA
94301
|
|
Contact |
gregory ramina |
|
Regulation Number | 892.2080
|
Classification Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 02/13/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Radiology
|
Review Advisory Committee |
Radiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
Predetermined Change Control Plan Authorized |
No
|
|
|