Synapse 3D Cardiac Tools— 510(k) K200973

Name: FDA 510(k) clearance K200973
Creator: U.S. Food and Drug Administration
Published: 2020-08-27

Substantially Equivalent

Fujifilm Corporaton

FDA 510(k) clearance K200973 for Synapse 3D Cardiac Tools, Substantially Equivalent on 2020-08-27. Applicant: Fujifilm Corporaton. Device class: 2.

Clearance details

Applicant: Fujifilm Corporaton
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-04-13
Decision date: 2020-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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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.