510(k) K162002— Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay

Substantially Equivalent

Zdi, Solutions, LLC

Clearance details

Applicant: Zdi, Solutions, LLC
Product code: Code IYE
Advisory panel: Radiology
Date received: 2016-07-20
Decision date: 2016-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.