ClearView cCAD— 510(k) K161959

Substantially Equivalent

Clearview Diagnostics, Inc.

FDA 510(k) clearance K161959 for ClearView cCAD, Substantially Equivalent on 2016-12-28. Applicant: Clearview Diagnostics, Inc..

Clearance details

Applicant: Clearview Diagnostics, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-07-18
Decision date: 2016-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

Download summary PDF View on FDA.gov ↗

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.