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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SIUI - 06938396400767

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300T
In Commercial Distribution

  • 06938396400767 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400446

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100S
In Commercial Distribution

  • 06938396400446 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400439

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100
In Commercial Distribution

  • 06938396400439 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400422

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100S
In Commercial Distribution

  • 06938396400422 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400415

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100
In Commercial Distribution

  • 06938396400415 ()


  • Portable basic diagnostic x-ray system, digital

Bone Drill - 14719878713112

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-PDL-01
In Commercial Distribution

  • 14719878713112 ()


  • Surgical planning/navigation-enhancement system

Minimally Invasive Spine Surgery Instruments - 14719878713099

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-02
In Commercial Distribution

  • 14719878713099 ()


  • Surgical planning/navigation-enhancement system

Central Monitoring System - 06944413800229

No Description
Edan Instruments, Inc.
MFM-CMS
In Commercial Distribution

  • 06944413800229 ()


  • Centralized patient monitor

Care Assist - 00884838127449

Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist Android
In Commercial Distribution

  • 00884838127449 ()
989803221541

  • Centralized patient monitor

Care Assist - 00884838127432

Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor

Patient Information Center iX - 00884838127067

Patient Information Center iX
Philips Medizin Systeme Böblingen GmbH
4.4
In Commercial Distribution

  • 00884838127067 ()
866389

  • Centralized patient monitor

MR-RT - 00884838107311

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Oy
RTgo 5.0 5
Not in Commercial Distribution

  • 00884838107311 ()
300005806302

  • MRI system application software

UroNav - 00884838107069

UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.
Philips DS North America LLC
UroNav 4
In Commercial Distribution

  • 00884838107069 ()
784039

  • Ultrasound imaging system application software

EchoNavigator - 00884838106437

Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.
Philips Medical Systems Nederland B.V.
EchoNavigator - 4
In Commercial Distribution

  • 00884838106437 ()


  • Angiographic x-ray system application software

Patient Information Center iX - 00884838104594

Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
Not in Commercial Distribution

  • 00884838104594 ()
866389

  • Centralized patient monitor

StentBoost Mobile - 00884838103450

StentBoost Mobile is a software product intended to provide a high resolution visualization of stents in vessels. It supports the physician in placing and deploying stents.
Philips India Limited
StentBoost Mobile
In Commercial Distribution

  • 00884838103450 ()
718160

  • Angiographic x-ray system application software

StentBoost Live - 00884838101890

Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents.
Philips Medical Systems Nederland B.V.
StentBoost Live - 2
In Commercial Distribution

  • 00884838101890 ()
001017

  • Angiographic x-ray system application software

Dynamic Coronary Roadmap - 00884838101883

Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.
Philips Medical Systems Nederland B.V.
Dynamic Coronary Roadmap - 3
In Commercial Distribution

  • 00884838101883 ()
001016

  • Angiographic x-ray system application software

MR-RT - 00884838098206

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain)
Philips Oy
MRCAT Brain / RTgo 4.1
In Commercial Distribution

  • 00884838098206 ()
781439

  • MRI system application software

DynaCAD - 00884838094857

DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application.
Philips DS North America LLC
5
In Commercial Distribution

  • 00884838094857 ()
4598-016-98182, 3000-103-14352, 300011916421

  • MRI system application software

Invivo - 00884838091818

UroNav Version 3
Philips DS North America LLC
459801572611
In Commercial Distribution

  • 00884838091818 ()


  • Ultrasound imaging system application software

Invivo - 00884838089648

UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.
Philips DS North America LLC
784026
In Commercial Distribution

  • 00884838089648 ()


  • Ultrasound imaging system application software

SmartPerfusion - 00884838088566

Software medical device used with a Philips Interventional X-Ray System. Provides color coded representation of digital subtraction angiography to assist diagnosis of perfusion alterations of tissues.
Philips Medical Systems Nederland B.V.
SmartPerfusion - 1
In Commercial Distribution

  • 00884838088566 ()
001119

  • Angiographic x-ray system application software

Dynamic Coronary Roadmap - 00884838086777

Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.
Philips Medical Systems Nederland B.V.
Dynamic Coronary Roadmap - 2
In Commercial Distribution

  • 00884838086777 ()
001016

  • Angiographic x-ray system application software

Patient Information Center iX - 00884838086715

Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
Not in Commercial Distribution

  • 00884838086715 ()
866389

  • Centralized patient monitor

Invivo - 00884838086630

DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application.
Philips DS North America LLC
4.0
In Commercial Distribution

  • 00884838086630 ()


  • MRI system application software

SmartCT - 00884838085732

Software medical device, used with a Philips Interventional X-Ray System. Assists physicians by providing 3D views of the anatomy combined with planning and life guidance functionality.
Philips Medical Systems Nederland B.V.
SmartCT - 1
In Commercial Distribution

  • 00884838085732 ()
001018

  • Angiographic x-ray system application software

Invivo - 00884838085510

DynaLync Prostate
Philips DS North America LLC
784016
Not in Commercial Distribution

  • 00884838085510 ()


  • MRI system application software

3D-CA - 00884838084773

Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run.
Philips Medical Systems Nederland B.V.
3D-CA - 3
In Commercial Distribution

  • 00884838084773 ()
001109

  • Angiographic x-ray system application software

3D-RA - 00884838084766

Software medical device, used with a Philips Interventional X-Ray System. Creates 3D views of vessels and bones from sets of 2D images from rotational angiographic runs.
Philips Medical Systems Nederland B.V.
3D-RA - 6
In Commercial Distribution

  • 00884838084766 ()
001102

  • Angiographic x-ray system application software

RTgo - 00884838084667

MR-RT RTgo software USB stick
Philips Oy
989603083082
In Commercial Distribution

  • 00884838084667 ()


  • MRI system application software

NA - 00884838083684

No Description
Philips Medical Systems Hsg
453564606081
In Commercial Distribution

  • 00884838083684 ()
453564606081

  • Centralized patient monitor

NA - 00884838083400

No Description
Philips Medical Systems Hsg
453564490671
In Commercial Distribution

  • 00884838083400 ()
453564490671

  • Centralized patient monitor

IntelliVue Patient Monitor MX750 - 00884838083332

The IntelliVue MX750 Patient Monitor has an optically-bonded 19 inch (469 mm) LCD (TFT) widescreen display with projected capacitive touch technology. It is compatible with various measurement modules and measurement servers. The monitor provides as standard a 100BaseT LAN port, an RS232 port, four USB ports, a basic nurse call relay, and an analog ECG sync output. MX750 also provides one MSL connector for connecting up to two FMX-4 module racks (in the case of two racks, the racks are connected to each other in series and then plugged in to the MSL connector). Built-in to the front of the display is a Contactless ID and Communication module using RFID technology. Please refer to technical data sheet for more information.
Philips Medizin Systeme Böblingen GmbH
IntelliVue Patient Monitor MX750
In Commercial Distribution

  • 00884838083332 ()
866471

  • Multiple vital physiological parameter monitoring system, clinical

Invivo - 00884838082885

DynaLoc Prostate 3.5
Philips DS North America LLC
98960321004
In Commercial Distribution

  • 00884838082885 ()


  • MRI system application software

NA - 00884838082694

No Description
Philips Medical Systems Hsg
453564606181
In Commercial Distribution

  • 00884838082694 ()
453564606181

  • Centralized patient monitor

NA - 00884838082687

No Description
Philips Medical Systems Hsg
453564606171
In Commercial Distribution

  • 00884838082687 ()
453564606171

  • Centralized patient monitor

NA - 00884838082670

No Description
Philips Medical Systems Hsg
453564606161
In Commercial Distribution

  • 00884838082670 ()
453564606161

  • Centralized patient monitor

NA - 00884838082663

No Description
Philips Medical Systems Hsg
453564606151
In Commercial Distribution

  • 00884838082663 ()
453564606151

  • Centralized patient monitor

NA - 00884838082656

No Description
Philips Medical Systems Hsg
453564606141
In Commercial Distribution

  • 00884838082656 ()
453564606141

  • Centralized patient monitor
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