FDA applicant

Mediso Medical Imaging Systems, Ltd.

Budapest, HU1 decision2025–20250 recalls

FDA records 1 decision for Mediso Medical Imaging Systems, Ltd. (Budapest, HU) in 2025: 1 510(k) clearance. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 2 predicates, 0 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 Mediso Medical Imaging Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Mediso Medical Imaging Systems, Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Mediso”

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

Mediso Medical Imaging Systems, Lttd. 1

Mediso Medical Imaging Systems, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Mediso”