FDA applicant

Astel, Inc.

Daejeon, KR1 decision2021–20210 recalls

FDA records 1 decision for Astel, Inc. (Daejeon, KR) in 2021: 1 510(k) clearance. All are in product code MQB (Solid State X-Ray Imager (Flat Panel/Digital…). 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 Astel, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Astel, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Astel, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?