K260755
- 510(k) number
- K260755
- Device name
- OptraSCAN System
- Applicant
- Optrascan, Inc. CA · US
- Product code
- NOT — Microscope, Automated, Image Analysis, Operator Inte
- Decision date
- 2026-07-02
- Date received
- 2026-03-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260755.pdf
Official FDA record: K260755
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.