510(k) Report

FDA applicant

Time Medical Limited

Shanghai, CN6 decisions2009–20230 recalls

FDA records 6 decisions for Time Medical Limited (Shanghai, CN) from 2009 to 2023: 6 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 6 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 Time Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2009: 22010: 12011: 12019: 12023: 1
2009high 2 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Time Medical Limited by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Time Medical Limited’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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Other applicant names beginning “Time”

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