Pinnacle Radiation Therapy Planning System— 510(k) K170086
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K170086 for Pinnacle Radiation Therapy Planning System, Substantially Equivalent on 2017-02-09. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fitchburg, WI, US
Recent devices under product code MUJ
view allMore clearances from Philips Medical Systems (Cleveland), Inc.
view allRecalls naming K170086
K-number listed on FDA's recall record- Z-2570-2025 — Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.
- Z-2239-2025 — Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- Z-1744-2022 — Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170086.
Data sourced from openFDA. This site is unofficial and independent of the FDA.