510(k) K241232

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

January 24, 2025

Date Received

May 2, 2024

Clearance Type

Traditional

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.