K241232 is an FDA 510(k) clearance for the Galen™ Second Read™. This device is classified as a Software Algorithm Device To Assist Users In Digital Pathology (Class II - Special Controls, product code QPN).
Submitted by Ibex Medical Analytics , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on January 24, 2025, 267 days after receiving the submission on May 2, 2024.
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 | K241232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2024 |
| Decision Date | January 24, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| 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. |