FDA applicant
Siemens Shenzhen Magnetic Resonance, Ltd.
FDA records 4 decisions for Siemens Shenzhen Magnetic Resonance, Ltd. (Shenzhen, CN) from 2025 to 2026: 4 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 141 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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
How often FDA has decided Siemens Shenzhen Magnetic Resonance, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
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