Digital Pathology Assist Software
Helps a pathologist work through a digitized slide, by finding, counting or measuring what would otherwise be counted by eye.
Pathologists spend real time counting things down a microscope. Cells, divisions, the share of tissue that stains a certain way. It is careful work, it is slow, and two experts genuinely disagree more often than patients would like to imagine.
Software in this group takes on the counting and measuring, on a slide that has been scanned into an image.
The word assist is the whole story. The pathologist reads the case and signs it. The software gets rid of the tallying.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- QPN
- FDA name for it
- Software Algorithm Device To Assist Users In Digital Pathology
- Rule number
- 21 CFR 864.3750
- Risk class
- Class 2
- Medical field
- Pathology
Before You Sign Anything
- Ask which scanners and stains it is cleared with. Pathology AI is unusually sensitive to both.
- Ask what it does with a poor quality slide, because a lab produces plenty of them.
- Ask how the result appears in your reporting system, and who is responsible when software and pathologist differ.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Ibex Medical Analytics , Ltd. | 1 |
| Paige.Ai | 1 |
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.