Synapse 3D Liver and Kidney Analysis— 510(k) K142521

Substantially Equivalent

Fujifilm Meidcal Systems U.S.A.,Inc.

FDA 510(k) clearance K142521 for Synapse 3D Liver and Kidney Analysis, Substantially Equivalent on 2014-12-01. Applicant: Fujifilm Meidcal Systems U.S.A.,Inc..

Clearance details

Applicant: Fujifilm Meidcal Systems U.S.A.,Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-09-08
Decision date: 2014-12-01
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.