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Philips Medical Systems (Cleveland), Inc.

Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.

Philips Medical Systems (Cleveland), Inc.

Manufacturer
🇺🇸 United States

Philips Medical Systems (Cleveland), Inc.

FDA registration
Philips Medical Systems (Cleveland), Inc.·3 products·🇺🇸 United States

Pinnacle3®

Device
EU MDD · Eu Md Class 2b ·Philips Medical Systems (Cleveland), Inc.·On the market·25 countries

Philips

FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838091122·Pinnacle3 Radiation therapy treatment planning ...

Philips

FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838098992·Pinnacle Radiation Therapy Planning System Vers...

Ingenuity Flex

FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838059528·

Pinnacle Radiation Therapy Planning System

FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838103566·

Philips

FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838085602·Pinnacle Radiation Therapy Planning System Vers...

Pinnacle Radiation Therapy Planning System

FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838102965·

Philips

FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838074200·Pinnacle Radiation Therapy Planning System Vers...

Ingenuity TF

FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838059443·

Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland), Inc.·November 14, 2012

Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 23, 2014

Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 10, 2013

Pinnacle3® Radiation Therapy Planning System

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Philips Medical Systems (Cleveland), Inc.·1 device

Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·March 6, 2014

Philips Brilliance 64 computed tomography x-ray system

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 6, 2017

Philips Ingenuity CT computed tomography x-ray system

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 6, 2017

Philips Ingenuity Core 128 computed tomography x-ray system

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 6, 2017