ECHOINSIGHT— 510(k) K110447

Substantially Equivalent

Ultrasound Medical Devices, Inc.

FDA 510(k) clearance K110447 for ECHOINSIGHT, Substantially Equivalent on 2011-05-27. Applicant: Ultrasound Medical Devices, Inc..

Clearance details

Applicant: Ultrasound Medical Devices, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2011-02-16
Decision date: 2011-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.