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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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IntelliSpace Portal - 00884838083646

The IntelliSpace Portal V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
Philips Medical Systems Nederland B.V.
6.5
Not in Commercial Distribution

  • 00884838083646 ()


  • CT system workstation

Invivo - 00884838081758

SensaVue Cart Assembly
Philips DS North America LLC
4535-303-46291
Not in Commercial Distribution

  • 00884838081758 ()
453530346291

  • MRI system workstation

ONLINE TDM Vancomyin Gen.3 - 04015630934447

No Description
Roche Diagnostics GmbH
06779344190
In Commercial Distribution

  • 04015630934447 ()
06779344190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Vancomyin Gen.3 - 04015630934416

No Description
Roche Diagnostics GmbH
06779336190
In Commercial Distribution

  • 04015630934416 ()
06779336190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Vancomycin Gen.3 - 07613336157800

No Description
Roche Diagnostics GmbH
08445605190
In Commercial Distribution

  • 07613336157800 ()
08445605190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE DAT Lysergic Acid Diethylamide - 07613336164891

No Description
Roche Diagnostics GmbH
08764778190
In Commercial Distribution

  • 07613336164891 ()
08764778190

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent

ONLINE TDM Vancomycin Gen.3 - 07613336121627

No Description
Roche Diagnostics GmbH
08058849190
Not in Commercial Distribution

  • 07613336121627 ()
08058849190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Carbamazepine Gen.4 - 07613336121108

No Description
Roche Diagnostics GmbH
08057435190
In Commercial Distribution

  • 07613336121108 ()
08057435190

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Acetaminophen Gen.2 - 07613336120934

No Description
Roche Diagnostics GmbH
08056684190
In Commercial Distribution

  • 07613336120934 ()
08056684190

  • Acetaminophen IVD, kit, spectrophotometry

Quantaras Contour Companion - 00860006956004

Automatic contouring for radiation treatment planning.
Quantitative Radiology Solutions LLC
QCCv1.0.0
Not in Commercial Distribution

  • 00860006956004 ()


  • Radiation therapy treatment planning workstation
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