K855063 is an FDA 510(k) clearance for the UNIVERSAL PATIENT CHAIR UNI 2000X. This device is classified as a Couch, Radiation Therapy, Powered (Class II - Special Controls, product code JAI).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on January 30, 1986, 43 days after receiving the submission on December 18, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5770.
| 510(k) Number | K855063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1985 |
| Decision Date | January 30, 1986 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JAI — Couch, Radiation Therapy, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5770 |