510(k) Report

FDA applicant

Visaris D.O.O. Belgrade

Zemun, RS2 decisions2015–20163 recalls

FDA records 2 decisions for Visaris D.O.O. Belgrade (Zemun, RS) from 2015 to 2016: 2 510(k) clearances. All are in product code KPR (System, X-Ray, Stationary). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

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

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

How often FDA has decided Visaris D.O.O. Belgrade’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015: 12016: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

3in 2018

2018: 3
2015high 3 (2018) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Visaris D.O.O. Belgrade by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Visaris D.O.O. Belgrade’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?

  • KPRSystem, X-Ray, Stationary2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade · 20161cites it
  • K150725Visaris AvanseVisaris D.O.O. Belgrade · 20151cites it

What has FDA decided for it lately?

  • K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade · 20163 recalls
  • K150725Visaris AvanseVisaris D.O.O. Belgrade · 2015

All 2 as Visaris D.O.O. Belgrade →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K160620Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision…Apr 5, 2018Class II
  • K160620Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision…Apr 5, 2018Class II
  • K160620Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision…Apr 5, 2018Class II