FDA applicant

Imactis, Sas

La Tronche, FR1 decision2018–20184 recalls

FDA records 1 decision for Imactis, Sas (La Tronche, FR) in 2018: 1 510(k) clearance. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 recalls are 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 Imactis, Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2026

2018high 1 (2019) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Imactis, Sas by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Imactis, Sas

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?