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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No Description
Roche Diagnostics GmbH
06779344190
In Commercial Distribution

  • 04015630934447 ()
06779344190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
06779336190
In Commercial Distribution

  • 04015630934416 ()
06779336190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08058849190
Not in Commercial Distribution

  • 07613336121627 ()
08058849190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08057435190
In Commercial Distribution

  • 07613336121108 ()
08057435190

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08056684190
In Commercial Distribution

  • 07613336120934 ()
08056684190

  • Acetaminophen IVD, kit, spectrophotometry
No Description
Roche Diagnostics GmbH
08764778190
In Commercial Distribution

  • 07613336164891 ()
08764778190

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08445605190
In Commercial Distribution

  • 07613336157800 ()
08445605190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Automatic contouring for radiation treatment planning.
Quantitative Radiology Solutions LLC
QCCv1.0.0
Not in Commercial Distribution

  • 00860006956004 ()


  • Radiation therapy treatment planning workstation
110~240V~ 120kV
DRGEM Corporation
JADE-40
In Commercial Distribution

  • 08800011150099 ()


  • Mobile basic diagnostic x-ray system, analogue
100~240V~ 120kV
DRGEM Corporation
JADE-32
In Commercial Distribution

  • 08800011150082 ()


  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003293 ()
CB50

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003286 ()
CB40

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003279 ()
CB32

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003262 ()
CB20

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003095 ()
BA32

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003088 ()
BA20

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003071 ()
BA16

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003064 ()
AA32

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003057 ()
AA20

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003040 ()
AA16

  • Mobile basic diagnostic x-ray system, analogue
Accuray Precision® Treatment Planning System
Accuray Incorporated
1049210-000
In Commercial Distribution

  • 00811376030221 ()
NA

  • Radiation therapy treatment planning workstation
Accuray Precision™ Treatment Planning System (Version 3.1)
Accuray Incorporated
1070891
In Commercial Distribution

  • 00811376030146 ()
NA

  • Radiation therapy treatment planning workstation
Accuray Precision™ Treatment Planning System (Version 3.0)
Accuray Incorporated
1063143
In Commercial Distribution

  • 00811376030092 ()
NA

  • Radiation therapy treatment planning workstation
4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
USWP-100A
Not in Commercial Distribution

  • 04987670102370 ()


  • Ultrasound imaging system workstation
ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
USWS-900A
In Commercial Distribution

  • 04987670101014 ()


  • Ultrasound imaging system workstation
ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
TUW-U001S
In Commercial Distribution

  • 04987670100796 ()


  • Ultrasound imaging system workstation
ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc.
FUJIFILM CORPORATION
MIS-1000
In Commercial Distribution

  • 04547410345438 ()


  • Radiology picture archiving and communication system workstation
The product “Synapse 3D” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis.
FUJIFILM CORPORATION
Synapse 3D
In Commercial Distribution

  • 04547410324877 ()


  • Radiology picture archiving and communication system workstation
MDNC-3421 HLX
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001695 ()
K9300345A

  • Radiology picture archiving and communication system workstation
MDNC-3421 DE NC
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001688 ()
K9300344A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDMG-5121
Not in Commercial Distribution

  • 05415334001589 ()
K9300508A

  • Radiology picture archiving and communication system workstation
MDMG-5221 CB
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001572 ()
K9300521B

  • Radiology picture archiving and communication system workstation
MDMG-5221
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001565 ()
K9300520B

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDCG-5121
Not in Commercial Distribution

  • 05415334001558 ()
K9301500B

  • Radiology picture archiving and communication system workstation
MDMG-5221 CB
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001534 ()
K9300521A

  • Radiology picture archiving and communication system workstation
MDMG-5221 BB
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001527 ()
K9300520A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDCC-4130
Not in Commercial Distribution

  • 05415334001510 ()
K9301605A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDCG-10130
Not in Commercial Distribution

  • 05415334001497 ()
K9301660A

  • Radiology picture archiving and communication system workstation
MDNG-5121 BB MA MKII
Barco NV
MDNG-5121
Not in Commercial Distribution

  • 05415334001459 ()
K9300267C

  • Radiology picture archiving and communication system workstation
E-3620 MA LORAD G
Barco NV
E-3620
Not in Commercial Distribution

  • 05415334001442 ()
K9300289D

  • Radiology picture archiving and communication system workstation
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