K001201 is an FDA 510(k) clearance for the MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on June 1, 2000, 49 days after receiving the submission on April 13, 2000.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K001201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2000 |
| Decision Date | June 01, 2000 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |