Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System— 510(k) K173000

Clearance details

Applicant

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

Product code

Code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2017-09-27

Decision date

2017-12-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shantou, CN

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• K261668 — Venue Go2026-08-07
• K262311 — Alturion Series Diagnostic Ultrasound System2026-08-04
• K261288 — Handheld Ultrasound Scanner2026-07-30

• K210317 — Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System2021-08-19
• K210318 — Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System2021-08-18
• K202350 — SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System2021-01-06
• K202353 — SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System2020-12-23
• K200637 — SR-8100 Portable X-ray Unit2020-07-09

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 →