510(k) Report

FDA applicant

Centervue S.P.A.

Padova, IT13 decisions2010–20250 recalls

FDA records 13 decisions for Centervue S.P.A. (Padova, IT) from 2010 to 2025: 13 510(k) clearances. Most are in product codes MYC (Ophthalmoscope, Laser, Scanning) and HLI (Ophthalmoscope, Ac-Powered). Its devices cite 22 predicates, 11 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Centervue S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2010: 22014: 22015: 12016: 12018: 22019: 12021: 22024: 12025: 1
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Centervue S.P.A. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Centervue S.P.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MYCOphthalmoscope, Laser, Scanning9decisions
  • HLIOphthalmoscope, Ac-Powered1decision
  • HPTPerimeter, Automatic, Ac-Powered1decision
  • NFJSystem, Image Management, Ophthalmic1decision
  • HKICamera, Ophthalmic, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 22 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K101935Centervue Digital Retinography SystemCentervue S.P.A. · 20105cite it
  • K142047EIDONCentervue S.P.A. · 20144cite it
  • K133758Centervue Macular Integrity AssessmentCentervue S.P.A. · 20142cite it
  • K150320CompassCentervue S.P.A. · 20151cites it
  • K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A. · 20211cites it
  • K092187Maia, Model 1Centervue S.P.A. · 20101cites it

What has FDA decided for it lately?

  • K243504Maia (AHMACME001)Centervue S.P.A. · 2025
  • K234076iCare ALTIUS CWCentervue S.P.A. · 2024
  • K213705DRSplusCentervue S.P.A. · 2021
  • K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A. · 2021
  • K192113DRSplusCentervue S.P.A. · 2019
  • K180526Eidon FACentervue S.P.A. · 2018
  • K180293Retia 2Centervue S.P.A. · 2018
  • K153181MAIACentervue S.P.A. · 2016

All 13 as Centervue S.P.A. →