QPN — Software Algorithm Device To Assist Users In Digital Pathology Class II
Classification Details
- Product Code
- QPN
- Device Class
- Class II
- Regulation Number
- 864.3750
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
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.