3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305— 510(k) K863043

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K863043 for 3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305, Substantially Equivalent on 1986-11-10. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1986-08-12
Decision date: 1986-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iselin, NJ, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.