Software Algorithm Device To Assist Users In Digital Pathology
The Software Algorithm Device to Assist Users in Digital Pathology is an in vitro diagnostic device intended to evaluate scanned pathology whole slide images, using software algorithms to provide information about the presence, location, and characteristics of areas with clinical implications, assisting the user in determining a pathology diagnosis. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 864.3750 in the Pathology specialty. It carries product code QPN and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QPN
- Device Class
- FDA class 2
- Regulation Number
- 864.3750
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.