K253893
- 510(k) number
- K253893
- Device name
- Harmony Referral System with Harmony OCT Viewer (Octave)
- Applicant
- Topcon Healthcare Solutions EMEA Oy FI
- Product code
- NFJ — System, Image Management, Ophthalmic
- Decision date
- 2026-06-04
- Date received
- 2025-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253893.pdf
Official FDA record: K253893
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.