SYNAPSE 3D CARDIAC TOOLS— 510(k) K120636

Substantially Equivalent

Fujifilm Medical System U.S.A., Inc.

FDA 510(k) clearance K120636 for SYNAPSE 3D CARDIAC TOOLS, Substantially Equivalent on 2012-07-05. Applicant: Fujifilm Medical System U.S.A., Inc..

Clearance details

Applicant: Fujifilm Medical System U.S.A., Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-03-01
Decision date: 2012-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, 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.