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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0.50mm X 0.5cm VISICOIL
Izi Medical Products, LLC
FP-05005
In Commercial Distribution

  • EIBAFP050050 ()
FP-05005

  • Radiological image marker, implantable
0.35mm X 0.5cm VISICOIL
Izi Medical Products, LLC
FP-03505
In Commercial Distribution

  • EIBAFP035050 ()
FP-03505

  • Radiological image marker, implantable
1.10mm X 3cm VISICOIL
Izi Medical Products, LLC
FP-0059
In Commercial Distribution

  • EIBAFP00590 ()
FP-0059

  • Radiological image marker, implantable
1.10mm X 2cm VISICOIL
Izi Medical Products, LLC
FP-0058
In Commercial Distribution

  • EIBAFP00580 ()
FP-0058

  • Radiological image marker, implantable
1.10mm X 1cm VISICOIL
Izi Medical Products, LLC
FP-0057
In Commercial Distribution

  • EIBAFP00570 ()
FP-0057

  • Radiological image marker, implantable
0.75mm X 6cm VISICOIL
Izi Medical Products, LLC
FP-0020
In Commercial Distribution

  • EIBAFP00200 ()
FP-0020

  • Radiological image marker, implantable
0.75mm X 3cm VISICOIL
Izi Medical Products, LLC
FP-0019
In Commercial Distribution

  • EIBAFP00190 ()
FP-0019

  • Radiological image marker, implantable
0.75mm X 4cm VISICOIL
Izi Medical Products, LLC
FP-0018
In Commercial Distribution

  • EIBAFP00180 ()
FP-0018

  • Radiological image marker, implantable
0.75mm X 3cm VISICOIL
Izi Medical Products, LLC
FP-0017
In Commercial Distribution

  • EIBAFP00170 ()
FP-0017

  • Radiological image marker, implantable
0.75mm X 2cm VISICOIL
Izi Medical Products, LLC
FP-0016
In Commercial Distribution

  • EIBAFP00160 ()
FP-0016

  • Radiological image marker, implantable
0.75mm X 1.0cm VISICOIL
Izi Medical Products, LLC
FP-0015
In Commercial Distribution

  • EIBAFP00150 ()
FP-0015

  • Radiological image marker, implantable
0.35mm X 6.0cm VISICOIL
Izi Medical Products, LLC
FP-0014
In Commercial Distribution

  • EIBAFP00140 ()
FP-0014

  • Radiological image marker, implantable
0.35mm X 5cm VISICOIL
Izi Medical Products, LLC
FP-0013
In Commercial Distribution

  • EIBAFP00130 ()
FP-0013

  • Radiological image marker, implantable
0.35mm X 4cm VISICOIL
Izi Medical Products, LLC
FP-0012
In Commercial Distribution

  • EIBAFP00120 ()
FP-0012

  • Radiological image marker, implantable
0.35mm X 3cm VISICOIL
Izi Medical Products, LLC
FP-0011
Not in Commercial Distribution

  • EIBAFP00110 ()
FP-0011

  • Radiological image marker, implantable
0.35 mm x 2 cm VISICOIL
Izi Medical Products, LLC
FP-0010
Not in Commercial Distribution

  • EIBAFP00100 ()
FP-0010

  • Radiological image marker, implantable
0.35 mm x 1 cm VISICOIL
Izi Medical Products, LLC
FP-0009
Not in Commercial Distribution

  • EIBAFP00090 ()
FP-0009

  • Radiological image marker, implantable
The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Philips Healthcare (Suzhou) Co., Ltd.
Incisive CT
In Commercial Distribution

  • 00884838105508 ()
728144

  • Full-body CT system
No Description
Philips Medical Systems Nederland B.V.
Spectral CT on Rails
In Commercial Distribution

  • 00884838103627 ()
728334

  • Full-body CT system
No Description
Philips Medical Systems Nederland B.V.
Spectral CT
In Commercial Distribution

  • 00884838101111 ()
728333

  • Full-body CT system
No Description
Philips Healthcare (Suzhou) Co., Ltd.
Incisive CT
Not in Commercial Distribution

  • 00884838085015 ()
728143

  • Full-body CT system
UroNAV Fusion Biopsy System
Philips DS North America LLC
784001
In Commercial Distribution

  • 00884838083592 ()


  • Stereotactic system application software
No Description
Philips Medical Systems Nederland B.V.
Brilliance 64
In Commercial Distribution

  • 00884838083325 ()
728231

  • Full-body CT system
UroNav Fusion Biopsy Software
Philips DS North America LLC
784015
In Commercial Distribution

  • 00884838081550 ()


  • Stereotactic system application software
UroNAV Fusion Biopsy System
Philips DS North America LLC
784012
In Commercial Distribution

  • 00884838081543 ()


  • Stereotactic system application software
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
8.x
Not in Commercial Distribution

  • 00884838073876 ()


  • Radiology DICOM image processing application software
No Description
Philips Medical Systems Nederland B.V.
Spectral CT System Upgrades
In Commercial Distribution

  • 00884838119253 ()
728335

  • Full-body CT system
The CT 5300 is a Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device includes data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components.
Philips Healthcare (Suzhou) Co., Ltd.
CT 5300
In Commercial Distribution

  • 00884838113237 ()
728285

  • Full-body CT system
No Description
Philips Medical Systems Nederland B.V.
Big Bore System Upgrade
In Commercial Distribution

  • 00884838098725 ()
728272

  • Full-body CT system
No Description
Philips Medical Systems Nederland B.V.
Brilliance iCT system Upgrade
In Commercial Distribution

  • 00884838098718 ()
728305

  • Full-body CT system
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