510(k) K241232
K241232 is an FDA 510(k) premarket notification submitted by Ibex Medical Analytics , Ltd. for the device "Galen Second Read". The FDA issued a decision of Substantially Equivalent on January 24, 2025. 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.
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.