510(k) Report

FDA applicant

E-Scopics

Aix-En-Provence, FR4 decisions2022–20260 recalls

FDA records 4 decisions for E-Scopics (Aix-En-Provence, FR) from 2022 to 2026: 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 82 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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 E-Scopics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 12026 (partial year): 2
2022high 2 (2026) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — E-Scopics by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like E-Scopics’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 4 510(k)s took a median of 82 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 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.

  • K232336ES Series V2E-Scopics · 20232cite it
  • K213102ES1 SystemE-Scopics · 20221cites it

What has FDA decided for it lately?

All 4 as E-Scopics →