R4 ACERT ULTRASOUND REPORTING SYSTEM— 510(k) K101898

Substantially Equivalent

R4, LLC

FDA 510(k) clearance K101898 for R4 ACERT ULTRASOUND REPORTING SYSTEM, Substantially Equivalent on 2011-09-15. Applicant: R4, LLC.

Clearance details

Applicant: R4, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2010-07-07
Decision date: 2011-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Strongsville, OH, 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.