Merge Cardio— 510(k) K192276

Substantially Equivalent

Merge Healthcare Incorporated

FDA 510(k) clearance K192276 for Merge Cardio, Substantially Equivalent on 2019-09-20. Applicant: Merge Healthcare Incorporated.

Clearance details

Applicant: Merge Healthcare Incorporated
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-08-22
Decision date: 2019-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hartland, WI, 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.