Software Algorithm Device To Assist Users In Digital Pathology
QPN is the FDA product code for Software Algorithm Device To Assist Users In Digital Pathology, a class II device type, regulated under 21 CFR 864.3750. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QPN
- Device name
- Software Algorithm Device To Assist Users In Digital 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.
- Regulation
- 21 CFR 864.3750
- Device class
- Class II
- Review panel
- Pathology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code QPN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code QPN| Applicant | Clearances |
|---|---|
| Ibex Medical Analytics, Ltd. | 1 |
| Paige.ai, Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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