Pinnacle Radiation Therapy Planning System

System, Planning, Radiation Therapy Treatment

Philips Medical Systems (Cleveland), Inc.

The following data is part of a premarket notification filed by Philips Medical Systems (cleveland), Inc. with the FDA for Pinnacle Radiation Therapy Planning System.

Pre-market Notification Details

• Device ID: K170086
• 510k Number: K170086
• Device Name: Pinnacle Radiation Therapy Planning System
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: Philips Medical Systems (Cleveland), Inc. 5520 Nobel Drive Fitchburg, WI 53711
• Contact: Michelle Godin
• Correspondent: Michelle Godin; Philips Medical Systems (Cleveland), Inc. 5520 Nobel Drive Fitchburg, WI 53711
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-10
• Decision Date: 2017-02-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838098992	K170086	000
00884838091122	K170086	000
00884838085602	K170086	000
00884838074200	K170086	000
00884838103566	K170086	000
00884838102965	K170086	000