510(k) Report

FDA applicant

Shanghai Chenguang Medical Technologies Co, Ltd.

Shanghai, CN8 decisions2007–20110 recalls

FDA records 8 decisions for Shanghai Chenguang Medical Technologies Co, Ltd. (Shanghai, CN) from 2007 to 2011: 8 510(k) clearances. All are in product code MOS (Coil, Magnetic Resonance, Specialty). Its devices cite 11 predicates, 3 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 Shanghai Chenguang Medical Technologies Co, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 22008: 22009: 12010: 22011: 1
2007high 2 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Chenguang Medical Technologies Co, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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