K133191 is an FDA 510(k) clearance for the PROBEAM PROTON THERAPY SYSTEM. This device is classified as a System, Radiation Therapy, Charged-particle, Medical (Class II - Special Controls, product code LHN).
Submitted by Varian Medical Systems (Palo Alto, US). The FDA issued a Cleared decision on January 10, 2014, 85 days after receiving the submission on October 17, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K133191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2013 |
| Decision Date | January 10, 2014 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LHN — System, Radiation Therapy, Charged-particle, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |