510(k) Report

FDA applicant

Sonoscanner Sarl

Ivry Sur Seine, FR4 decisions2015–20240 recalls

FDA records 4 decisions for Sonoscanner Sarl (Ivry Sur Seine, FR) from 2015 to 2024: 4 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sonoscanner”.

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 Sonoscanner Sarl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2015: 12017: 12020: 12024: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

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

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

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 105 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 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.

  • K143601U-LiteSonoscanner Sarl · 20151cites it
  • K171164U-Lite EXPSonoscanner · 20171cites it
  • K201988T-LiteSonoscanner · 20201cites it

What has FDA decided for it lately?

  • K232285U-Lite PROSonoscanner Sarl · 2024
  • K201988T-LiteSonoscanner · 2020
  • K171164U-Lite EXPSonoscanner · 2017
  • K143601U-LiteSonoscanner Sarl · 2015

All 2 as Sonoscanner Sarl →All 2 as Sonoscanner →