510(k) Report

FDA applicant

Qr S.R.L.

Verona, IT4 decisions2011–20160 recalls

FDA records 4 decisions for Qr S.R.L. (Verona, IT) from 2011 to 2016: 4 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 2 predicates, 1 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, radiology panel, where it files most

How often FDA has decided Qr S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12013: 12015: 12016: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Qr S.R.L. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Qr S.R.L.’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?

  • OASX-Ray, Tomography, Computed, Dental3decisions
  • JAKSystem, X-Ray, Tomography, Computed1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K130442Newtom Vgi and Newtom 5GQr S.R.L. · 20131cites it
  • K142222NewTom 5GQr S.R.L. · 20151cites it

What has FDA decided for it lately?

  • K151612NewTom VGi evoQr S.R.L. · 2016
  • K142222NewTom 5GQr S.R.L. · 2015
  • K130442Newtom Vgi and Newtom 5GQr S.R.L. · 2013
  • K110260Newtom 5G / Newtom 5G Version FPQr S.R.L. · 2011

All 4 as Qr S.R.L. →