Ziostation2— 510(k) K181892

Substantially Equivalent

Ziosoft, Inc.

FDA 510(k) clearance K181892 for Ziostation2, Substantially Equivalent on 2018-10-09. Applicant: Ziosoft, Inc..

Clearance details

Applicant: Ziosoft, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2018-07-13
Decision date: 2018-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minato-Ku, 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.