Cleared Special

K170086 - Pinnacle Radiation Therapy Planning System

K170086 is an FDA 510(k) clearance for Pinnacle Radiation Therapy Planning System, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Special 510(k) pathway after a 30-day FDA review.

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

K170086 is an FDA 510(k) clearance for the Pinnacle Radiation Therapy Planning System. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Fitchburg, US). The FDA issued a Cleared decision on February 9, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K170086

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 210
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K170086.
Eclipse Treatment Planning System
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K162370 · Siemens Medical Solutions USA, Inc. · Oct 2016
Precision Treatment Planning System
K161136 · Accuray Incorporated · Jun 2016
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K160093 · RaySearch Laboratories AB (PUBL) · Apr 2016