QPN
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Software Algorithm Device To Assist Users In Digital Pathology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.3750
- Medical specialty
- Pathology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Galen™ Second Read™ (K241232) | Ibex Medical Analytics , Ltd. | 2025-01-24 |
| Paige Prostate (DEN200080) | Paige.Ai | 2021-09-21 |
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