K170086 is an FDA 510(k) clearance for the Pinnacle Radiation Therapy Planning System. This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Philips Medical Systems (Cleveland), Inc. (Fitchburg, US). The FDA issued a Cleared decision on February 9, 2017, 30 days after receiving the submission on January 10, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K170086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2017 |
| Decision Date | February 09, 2017 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUJ — System, Planning, Radiation Therapy Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |