Cleared Traditional

K182683 - Z-Robot Patient Positioning System
(FDA 510(k) Clearance)

K182683 · Chinan Biomedical Technology, Inc. · Radiology

Jun 2019

Decision

274d

Days

Class 2

Risk

K182683 is an FDA 510(k) clearance for the Z-Robot Patient Positioning System. This device is classified as a Couch, Radiation Therapy, Powered (Class II — Special Controls, product code JAI).

Submitted by Chinan Biomedical Technology, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on June 27, 2019, 274 days after receiving the submission on September 26, 2018.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5770.

Submission Details

510(k) Number	K182683 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2018
Decision Date	June 27, 2019
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF