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.
| 510(k) Number | K182683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | JAI - Couch, Radiation Therapy, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5770 |