510(k) DEN200080
DEN200080 is an FDA 510(k) premarket notification submitted by Paige.Ai for the device "Paige Prostate". The FDA issued a decision of De Novo Granted on September 21, 2021. The device falls under product code QPN (Software Algorithm Device To Assist Users In Digital Pathology), a Class II device regulated under 21 CFR 864.3750. Paige.Ai has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 21, 2021
- Date Received
- December 31, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software Algorithm Device To Assist Users In Digital Pathology
- Device Class
- Class II
- Regulation Number
- 864.3750
- Review Panel
- PA
- Submission Type
A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis.