Device Classification Name |
software algorithm device to assist users in digital pathology
|
De Novo Number |
DEN200080 |
Device Name |
Paige Prostate |
Requester |
paige.ai |
11 times square 37th floor |
new york city,
NY
10036
|
|
Contact |
emre gulturk |
|
Regulation Number | 864.3750
|
Classification Product Code |
|
Date Received | 12/31/2020 |
Decision Date | 09/21/2021 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Pathology
|
Review Advisory Committee |
Pathology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
Predetermined Change Control Plan Authorized |
No
|
|
|