Ziostation2— 510(k) K151212

Substantially Equivalent

Qi Imaging, LLC

FDA 510(k) clearance K151212 for Ziostation2, Substantially Equivalent on 2015-11-04. Applicant: Qi Imaging, LLC.

Clearance details

Applicant: Qi Imaging, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2015-05-06
Decision date: 2015-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, 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.