Harmony Referral System with Harmony OCT Viewer (Octave)— 510(k) K253893
Substantially EquivalentTopcon Healthcare Solutions EMEA Oy
FDA 510(k) clearance K253893 for Harmony Referral System with Harmony OCT Viewer (Octave), Substantially Equivalent on 2026-06-04. Applicant: Topcon Healthcare Solutions EMEA Oy. Device class: 2.
Clearance details
- Applicant
- Topcon Healthcare Solutions EMEA Oy
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oulu, FI
Recent devices under product code NFJ
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