510(k) Report

FDA applicant

Sino Canada Health Engineering Research Institute (Hefei)

Hefei, CN1 decision2023–20230 recalls

FDA records 1 decision for Sino Canada Health Engineering Research Institute (Hefei) (Hefei, CN) in 2023: 1 510(k) clearance. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). 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 Sino Canada Health Engineering Research Institute (Hefei)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Sino Canada Health Engineering Research Institute (Hefei) by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Sino”

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