510(k) Report

FDA applicant

Asg Superconductors S.P.A.

Genova, IT4 decisions2019–20240 recalls

FDA records 4 decisions for Asg Superconductors S.P.A. (Genova, IT) from 2019 to 2024: 4 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 62 for FDA’s reviews in the same codes and years. Its devices cite 9 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 Asg Superconductors S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 32024: 1
2019high 3 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Asg Superconductors S.P.A. 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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 78 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 62 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 9 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.

  • K190524MRopen 0.5 TAsg Superconductors S.P.A. · 20191cites it
  • K193116MRopen EVOAsg Superconductors S.P.A. · 20191cites it

What has FDA decided for it lately?

  • K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024
  • K193116MRopen EVOAsg Superconductors S.P.A. · 2019
  • K192690Upgrade Kit MR GUI PRO, MrJ 3300 PlusAsg Superconductors S.P.A. · 2019
  • K190524MRopen 0.5 TAsg Superconductors S.P.A. · 2019

All 4 as Asg Superconductors S.P.A. →