NFJ

System, Image Management, Ophthalmic

Product code
NFJ
Device name
System, Image Management, Ophthalmic
Device class
Class 2
21 CFR
21 CFR 892.2050
Medical specialty
Radiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
6
Summaries archived here
6 (direct download)
510(k) clearances (all years, FDA)
53 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (6)

Last three years. Most recent: 2026-07-17.

NumberDecision dateApplicantDevice nameSummary
K2606942026-07-17Carl Zeiss Meditec, AGZEISS CLINIC 360PDF
K2538932026-06-04Topcon Healthcare Solutions EMEA OyHarmony Referral System with Harmony OCT Viewer (Oct…PDF
K2340762024-08-22Centervue S.P.A.iCare ALTIUS CWPDF
K2328282024-03-01Topcon CorporationIMAGEnet6 Ophthalmic Data SystemPDF
K2329442023-12-21Carl Zeiss Meditec, AGCALLISTO eyePDF
K2325552023-11-20Topcon Healthcare SolutionsHarmonyPDF

6 summaries are archived here for direct download.

Official FDA classification page: NFJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).