K953894 is an FDA 510(k) clearance for the SIEMENS MULTILEAF COLLIMATOR. This device is classified as a Block, Beam-shaping, Radiation Therapy (Class II - Special Controls, product code IXI).
Submitted by Siemens Medical Solutions USA, Inc. (Concord, US). The FDA issued a Cleared decision on November 13, 1995, 88 days after receiving the submission on August 17, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5710.
| 510(k) Number | K953894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1995 |
| Decision Date | November 13, 1995 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXI — Block, Beam-shaping, Radiation Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5710 |