FDA applicant

iMediSync, Inc.

Seoul, KR2 decisions2022–20230 recalls

FDA records 2 decisions for iMediSync, Inc. (Seoul, KR) from 2022 to 2023: 2 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and OLU (Normalizing Quantitative Electroencephalograph…). 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, neurology panel, where it files most

How often FDA has decided iMediSync, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

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iMediSync, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?