DEN200080 is an FDA 510(k) submission for the Paige Prostate. This device is classified as a Software Algorithm Device To Assist Users In Digital Pathology (Class II - Special Controls, product code QPN).
Submitted by Paige.Ai (New York, US). The FDA issued a Not Cleared (DENG) decision on September 21, 2021.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3750. 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..
| 510(k) Number | DEN200080 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 31, 2020 |
| Decision Date | September 21, 2021 |
| Days to Decision | 264 days |
| Submission Type | Direct |
| Review Panel | Pathology (PA) |
| Summary | - |
| Product Code | QPN - Software Algorithm Device To Assist Users In Digital Pathology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.3750 |
| Definition | 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. |