Synapse 3D Blood Flow Analysis— 510(k) K191544

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K191544 for Synapse 3D Blood Flow Analysis, Substantially Equivalent on 2019-10-18. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-06-11
Decision date: 2019-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minato-Ku, Tokyo, JP

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.