Data / Medical devices / United States / OptraSCAN Inc.
OptraSCAN Inc.: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance
OptraSCAN Inc. is registered with the FDA (registration 3043127271) in San Jose, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 2, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3043127271
- Address
- 2001 Gateway Pl Ste 150w, San Jose, CA, United States, 95110
- Owner or operator
- OptraSCAN Inc (10096174)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 16, 2026
- Registered through
- 2027
- Brand names listed
- OptraSCAN System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Microscope, Automated, Image Analysis, Operator Intervention | NOT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 2, 2026 | K260755 | OptraSCAN System | NOT | Substantially Equivalent | Optrascan, Inc. | accessdata.fda.gov |
Compare with other makers
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.