MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01— 510(k) K092230

Clearance details

Applicant

Time Medical Limited

Product code

Code LNH

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2009-07-23

Decision date

2009-11-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shanghai, CN

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Death

11

Injury

670

Malfunction

1,460

Other

2

Total

2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →