Data / Medical devices / Microscope, Automated, Image Analysis, Operator Intervention
Microscope, Automated, Image Analysis, Operator Intervention (NOT): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Microscope, Automated, Image Analysis, Operator Intervention (product code NOT, Class 2, 21 CFR 864.1860). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on July 2, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NOT
- Device class
- 2
- Regulation
- 864.1860
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Israel | 1 |
Makers of Microscope, Automated, Image Analysis, Operator Intervention
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| OptraSCAN Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer | 1 | July 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Applied Spectral Imaging, Ltd. | Yokneam Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventana Medical Systems, Inc. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.