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— 510(k) K162002

Name: FDA 510(k) clearance K162002
Creator: U.S. Food and Drug Administration
Published: 2016-11-01

Substantially Equivalent

Zdi, Solutions, LLC

FDA 510(k) clearance K162002 for 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 on 2016-11-01. Applicant: Zdi, Solutions, LLC. Device class: 2.

Clearance details

Applicant: Zdi, Solutions, LLC
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2016-07-20
Decision date: 2016-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

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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.