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510(k) Data Aggregation
K Number
K093355Device Name
PCR ELEVA 1.2
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2010-01-08
(73 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PCR Eleva System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The PCR Eleva system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.
Device Description
A PCR Eleva consists of one or more workspots with PCR Eleva Software and one or more image plate readers. All components are connected via standard ethernet. The system complies with the ACR/NEMA DICOM Version 3 Digital Image Communication in Medicine Standard. Imaging plates are exposed via conventional X-Ray devices. The imaging plates used in PCR systems are coated with a luminescent material which acts as an x-ray detector. It stores the x-ray image in the form of excited charge carriers. An exposed imaging plate is loaded into the image reader of the PCR Eleva system and the image stored on the imaging plate is scanned with a laser and converted to digital data. The digital X-ray image data is then routed to the Eleva workstation for image processing, viewing, storing and/or printing to film if the workstations are connected to a compatible laser imager. The Eleva Workspot is also used for the scheduling of patients and exams. The Eleva Workstation consists of a PC, a keyboard, a monitor, and an optional bar-code reader.
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K Number
K090808Device Name
PINNACLE3 SMARTARC
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2009-04-03
(9 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pinnacle 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.
Pinnacle 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.
SmartArc is a module for creating intensity modulated arc therapy plans.
Device Description
The SmartArc module is an extension of PIMRT that adds dynamic arc capabilities. A Dynamic Arc beam is similar to the current Conformal Arc bean but does ot impose the restrictions of a constant does rate or blocking a specific target.
The SmartArc solution utilizes continuous gantry motion in which the field shape defined by a multi-leaf collimator changes during gantry rotation. The dose rate can also be changed during rotation of the gantry.
Creation of a Dynamic Arc beam will be accomplished through a SmartArc optimization. The user will create a default Dynamic Arc beam, enter IMRT, assign objectives and perform a SmartArc optimization to provide an intensity Modulated Arc Treatment )IMAT) plan.
This extends the functionality of the Pinnacle3 Radiation Therapy Planning System (hereafter Pinnacle RTP) that provides radiation therapy planning for the treatment of benign or malignant diseases. When using Pinnacle RTP, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. Pinnacle RTP can provide plans for various radiation therapy modalities including External Beam Treatment, Stereotactic Radiosurgery, and Brachytherapy.
Pinnacle RTP is a software package that runs on a Sun UNIX workstation and consists of a core software module (Pinnacle') and optional software features. These optional software features, commonly referred to as "plug-ins", are typically distributed separate from the core software product (separate CD-ROM). The device has network capability to other Pinnacle RTP workstations and to both input and output devices via local area network (LAN) or wide area network (WAN).
This software automates multi-modality image registration and fusion by overlaying images from CT. MR. PET. PET-CT, and SPECT devices. This feature provides clinicians with the ability to relate, interpret and contour and image's anatomic and functional information.
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K Number
K071391Device Name
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2007-09-07
(112 days)
Product Code
MSX
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HeartStart 12 Lead Transfer Station SW provides a diagnostic 12 lead ECG interface between Philips defibrillators and ECG management systems that can process XML formatted ECGs, such as the TraceMasterVue ECG Management system.
The HeartStart 12 Lead Transfer Station also allows viewing, printing, archiving and further distribution of digitized ECG records.
Device Description
The 12 Lead Transfer Station facilitates transmission of diagnostic 12 Lead ECG reports from Philips Defibrillators to ECG Management systems that recognize and accept digitized ECG records using the Philips published ECG schema. The Philips TraceMasterVue ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records. TraceMasterVue communicates with Web-based clients, faxes, printers etc through an industry-standard client/server network with other hospital information systems.
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K Number
K063783Device Name
PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2007-04-27
(127 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips reusable and disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.
Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T: M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.
Philips SpO2 Reusable Clip Sensor Model M1196T: M1196A and M1196T are indicated for patients > 40 kg (typically adult patients).
Philips Disposable SpO2 Sensor M1131A: M1131A is indicated for adult patients/pediatric patients
Philips Disposable SpO2 Sensors M1132A and M1133A: M1132A is indicated for infant patients, and M1133A for adult/infant/neonatal patients.
Device Description
Not Found
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K Number
K041741Device Name
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2004-07-21
(23 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
M3290A: For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Device Description
The Philips M3290A IntelliVue Information Center Software Release F.0 and M4840A Philips Telemetry System II with M4841A patient device.
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K Number
K040955Device Name
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2004-05-12
(29 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Device Description
M3290A IntelliVue Information Center Software Release E.01 and IntelliVue Clinical Network on VLAN. The modification is a change that permits operation of the IntelliVue Clinical Network on customer provided IEEE 802.1q compatible VLAN network infrastructure.
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K Number
K040404Device Name
HEARTSTART MRX, MODEL M3535A
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2004-05-04
(77 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cadex Battery Charger for Philips HeartStart Batteries is used to recharge and analyze rechargeable batteries that are used with Philips HeartStart manual defibrillator/monitors.
Device Description
The Cadex Battery Charger for Philips HeartStart Batteries is used to charge and analyze rechargeable batteries used in Philips HeartStart defibrillators. The Battery Charger consists of a commercially available battery charger and an adapter specifically designed to interface with the Philips HeartStart batteries. The battery charger is available in 2- and 4-bay models, which allow for the simultaneous charging of up to 4 batteries. The adapters allow for the mechanical interface between the battery and the battery charger. The adapters also contain the software that allows the battery charger to charge the battery using the appropriate algorithm for the type of battery being charged. The battery charger also analyzes a battery to determine its capacity.
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K Number
K040357Device Name
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2004-03-03
(19 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
M3290A: For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Device Description
The M3290A IntelliVue Information Center Software Release F.0 and M4840A Telemetry System II with M4841A TelePac+. The modification is a change that modifies the ECG processing, adds 4 high priority SpO2 limit alarm conditions and waveform export, and changes the radio technology.
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K Number
K032979Device Name
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2004-02-20
(149 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips Reusable SpO2 Sensors are intended for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation.
M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.
Device Description
The Philips SpO2 devices measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode.
The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called Ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb].
SpO2 = [HbO2]/([Hb]+[HbO2])
Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%), the Ratio can be related to a SpO2 value.
The devices contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value.
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K Number
K033715Device Name
PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Date Cleared
2004-02-13
(79 days)
Product Code
DQA, DPZ
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and hospital environments.
Device Description
picoSAT II SpO2 pulse oximetry module and M3001A Multi-Measurement Server
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