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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

K162002 Class II Traditional
Decision Date
2016-11-01
Sponsor / Applicant
Zdi, Solutions, LLC

Technical Specification

510(k) Submission ID K162002
Product Code IYE
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.5050
Decision Date 2016-11-01
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

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 received FDA 510(k) clearance under submission number K162002, sponsored by Zdi, Solutions, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-11-01.

Classification & Regulation

This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.