FDA applicant

Isys Medizintechnik GmbH

Kitzbuehel, AT3 decisions2014–20230 recalls

FDA records 3 decisions for Isys Medizintechnik GmbH (Kitzbuehel, AT) from 2014 to 2023: 3 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). 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 Isys Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Isys Medizintechnik GmbH by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Isys Medizintechnik GmbH’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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Other applicant names beginning “Isys”

FDA records each applicant name separately; these may or may not be the same firm.

Isys Medical, Ltd. 1

Isys Medizintechnik GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Isys”