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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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X100 with Processing Unit and FF-PBS application. Includes: - X100 Scanner - X100 Processing Unit - X100 User Maintenance Kit
SCOPIO LABS LTD
SC-SYS-00001
In Commercial Distribution

  • 07290018417133 ()


  • Cell morphology analyser IVD, automated/semi-automated
X100HT Processing Unit (Complete Unit)
SCOPIO LABS LTD
SC-SYS-00006
In Commercial Distribution

  • 07290018417126 ()


  • Cell morphology analyser IVD, automated/semi-automated
X100HT Digital Scanner (Complete Unit)
SCOPIO LABS LTD
SC-SYS-00005
In Commercial Distribution

  • 07290018417096 ()


  • Cell morphology analyser IVD, automated/semi-automated
The processing unit connected to the X100 digital scanner
SCOPIO LABS LTD
SC-SYS-00004
In Commercial Distribution

  • 07290018417072 ()


  • Cell morphology analyser IVD, automated/semi-automated
X100 Digital Scanner (Complete Unit)
SCOPIO LABS LTD
SC-SYS-00003
In Commercial Distribution

  • 07290018417034 ()


  • Cell morphology analyser IVD, automated/semi-automated
The Evoya Software Platform is an in vitro diagnostics modular software intended to be used together with Neonatal screening assay systems to enable workflow activities, data management, results analysis and reporting. The EVOYA Software Platform is intended to be used by trained laboratory professionals. The Evoya Software Platform is intended for in vitro diagnostic use.
Wallac Oy
5021-1000
In Commercial Distribution

  • 06438147366804 ()
5021-1000

  • Clinical laboratory information system
Software medical device, used with a Philips Interventional X-Ray System. Creates a CT based 3D model of the coronary vessel tree. Provides a composite image of 2D X-ray exposure image and 3D model.
Philips Medical Systems Nederland B.V.
CT Trueview - 2
In Commercial Distribution

  • 00884838064782 ()
001010

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure.
Philips Medical Systems Nederland B.V.
VesselNavigator - 1
In Commercial Distribution

  • 00884838064775 ()
001013

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Intended to assist with saccular cerebral aneurysm embolization, by visualizing and quantifying blood flow changes.
Philips Medical Systems Nederland B.V.
AneurysmFlow - 1
In Commercial Distribution

  • 00884838064768 ()
001015

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Reconstructs 3D volumes from rotational fluoroscopic acquisitions and provides CT-like images to assist the physician.
Philips Medical Systems Nederland B.V.
XperCT Dual - 3
In Commercial Distribution

  • 00884838059306 ()
001105

  • Angiographic x-ray system application software
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