Data / Medical devices / United States / Philips Medical Systems (Cleveland), Inc.

Philips Medical Systems (Cleveland), Inc.: FDA-registered device maker in Gainesville, FL, United States, 8 510(k) clearances

Name: Philips Medical Systems (Cleveland), Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips Medical Systems (Cleveland), Inc. is registered with the FDA (registration 3018004899) in Gainesville, FL, United States. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 9, 2017. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3018004899
Address: 3630 SW 47th Avenue, Gainesville, FL, United States, 32608
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 1, 2007
Registered through: 2026
Brand names listed: P3IMRT, Pinnacle 3 Radiation Therapy Planning System, Pinnacle Radiation Therapy Planning System version 16.2, Pinnacle3, Pinnacle3 Apex, Pinnacle3 Rad Therapy Plan System, Pinnacle3 Radiation Therapy Planning System, Pinnacle3 Radiation Therapy Planning System SmartArc Module and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Planning, Radiation Therapy Treatment	MUJ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 9, 2017	K170086	Pinnacle Radiation Therapy Planning System	MUJ	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
April 3, 2009	K090808	PINNACLE3 SMARTARC	MUJ	Substantially Equivalent	Philips Medical Systems, Inc.	accessdata.fda.gov
June 25, 2004	K041577	PINNACLE3 RADIATION THERAPY PLANNING SYSTEM	LNH	Substantially Equivalent	Adac Laboratories	accessdata.fda.gov
October 9, 2003	K032724	PINNACLE3 RADIATION THERAPY PLANNING SYSTEM	MUJ	Substantially Equivalent	Adac Laboratories	accessdata.fda.gov
February 2, 2001	K002237	P3IMRT TM	MUJ	Substantially Equivalent	Adac Laboratories	accessdata.fda.gov
April 7, 2000	K993923	ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM	MUJ	Substantially Equivalent	Adac Laboratories	accessdata.fda.gov
April 8, 1996	K951581	PINNACLE3 APEX	IYE	Substantially Equivalent	Adac Laboratories	accessdata.fda.gov
October 4, 1994	K926008	PINNACLE 3	IYE	Substantially Equivalent	Adac Laboratories	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 5, 2025	97049	Class II	Ongoing	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)16.2.0.6	Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.	accessdata.fda.gov
July 17, 2025	97309	Class II	Ongoing	Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software	Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR)	accessdata.fda.gov
August 30, 2022	90819	Class II	Ongoing	Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.	When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.	accessdata.fda.gov

Compare with other makers

Updated September 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.