The following data is part of a premarket notification filed by Chinan Biomedical Technology, Inc. with the FDA for Z-robot Patient Positioning System.
| Device ID | K182683 |
| 510k Number | K182683 |
| Device Name: | Z-Robot Patient Positioning System |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | Chinan Biomedical Technology, Inc. 6F., No.16, Sec.2 , Shengyi Rd., Zhubei City Hsinchu County, TW 302 |
| Contact | James Chinan Chen |
| Correspondent | James Chinan Chen Chinan Biomedical Technology, Inc. 6F., No.16, Sec.2 , Shengyi Rd., Zhubei City Hsinchu County, TW 302 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-26 |
| Decision Date | 2019-06-27 |