Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System— 510(k) K160853

Clearance details

Applicant

Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

Product code

Product code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2016-03-28

Decision date

2016-06-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shantou, CN

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Death

25

Injury

163

Malfunction

1,538

Other

4

Total

1,730

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 →