510(k) Report

FDA applicant

A.T.S. Applicazione Tecnologie Speciali S.R.L.

Torre De Roveri, IT4 decisions2019–20250 recalls

FDA records 4 decisions for A.T.S. Applicazione Tecnologie Speciali S.R.L. (Torre De Roveri, IT) from 2019 to 2025: 4 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 77 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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 A.T.S. Applicazione Tecnologie Speciali S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12021: 22025: 1
2019high 2 (2021) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — A.T.S. Applicazione Tecnologie Speciali S.R.L. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System3decisions
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 77 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 104 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K182086Arco FPA.T.S. Applicazione Tecnologie Speciali S.R.L. · 20192cite it

What has FDA decided for it lately?

  • K250282Persona C HRA.T.S. Applicazione Tecnologie Speciali S.R.L. · 2025
  • K211777Arco FP-SA.T.S. Applicazione Tecnologie Speciali S.R.L. · 2021
  • K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L. · 2021
  • K182086Arco FPA.T.S. Applicazione Tecnologie Speciali S.R.L. · 2019

All 4 as A.T.S. Applicazione Tecnologie Speciali S.R.L. →