K050422 is an FDA 510(k) clearance for the 550 TXT TREATMENT TABLE. This device is classified as a Couch, Radiation Therapy, Powered (Class II - Special Controls, product code JAI).
Submitted by Siemens Medical Solutions USA, Inc. (Concord, US). The FDA issued a Cleared decision on March 18, 2005, 28 days after receiving the submission on February 18, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5770.
| 510(k) Number | K050422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2005 |
| Decision Date | March 18, 2005 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |