ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System— 510(k) K202683

Clearance details

Applicant

Siemens Medical Solutions USA, Inc.

Product code

Product code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2020-09-15

Decision date

2020-10-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Issaquah, WA, US

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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 →