Z-Robot Patient Positioning System

FDA 510(k) K182683 · Chinan Biomedical Technology, Inc.

Substantially Equivalent

510(k) numberK182683

Submission

Device name
Z-Robot Patient Positioning System
Applicant
Chinan Biomedical Technology, Inc.
Hsinchu County, TW
Received
September 26, 2018
Decision date
June 27, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAI – Couch, Radiation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5770
Specialty
Radiology

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K120520Exactrac Robotics Novalis RoboticsJAI · Traditional Brainlab AG06/29/2012SE
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Questions and answers

When was Z-Robot Patient Positioning System cleared by the FDA?

Z-Robot Patient Positioning System (K182683) received a 510(k) decision of Substantially Equivalent on June 27, 2019, 274 days after the submission was received.

What is the product code of K182683?

The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.