SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES— 510(k) K904017

Substantially Equivalent

Siemens Ultrasound, Inc.

FDA 510(k) clearance K904017 for SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES, Substantially Equivalent on 1991-03-21. Applicant: Siemens Ultrasound, Inc..

Clearance details

Applicant: Siemens Ultrasound, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 1990-08-30
Decision date: 1991-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

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Adverse events under product code IYN

product code IYN

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.