Cleared Special

Pinnacle Radiation Therapy Planning System

K170086 · Philips Medical Systems (Cleveland), Inc. · Radiology
Feb 2017
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K170086 is an FDA 510(k) clearance for the Pinnacle Radiation Therapy Planning System, 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 review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K170086 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050