Synapse 3D, Synapse 3D Base Tools v6.1— 510(k) K203103

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K203103 for Synapse 3D, Synapse 3D Base Tools v6.1, Substantially Equivalent on 2021-02-09. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-10-14
Decision date: 2021-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 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.