MR Wireless Gating System, Model WGS-100— 510(k) K171778

Clearance details

Applicant

Ivy Biomedical Systems, Inc.

Product code

Code LNH

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2017-06-15

Decision date

2018-03-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Branford, CT, US

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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 →