510(k) Report

FDA applicant

Vinbrain Joint Stock Company

Viet Hung Ward, Long Bien District, VN2 decisions2022–20240 recalls

FDA records 2 decisions for Vinbrain Joint Stock Company (Viet Hung Ward, Long Bien District, VN) from 2022 to 2024: 2 510(k) clearances. Most are in product codes QFM (Radiological Computer-Assisted Prioritization…) and QIH (Automated Radiological Image Processing Software). 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 Vinbrain Joint Stock Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12024: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like Vinbrain Joint Stock Company’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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