uMR Omega— 510(k) K230152

Clearance details

Applicant

Shanghai United Imaging Healthcare Co., Ltd.

Product code

Code LNH

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2023-01-19

Decision date

2023-05-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shanghai, CN

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• K260524 — uMI Panvivo (5 models)2026-04-03

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 →