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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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Diagnostic Ultrasound System
FUJIFILM CORPORATION
ARIETTA 750
In Commercial Distribution



  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
FUJIFILM CORPORATION
ARIETTA 70
In Commercial Distribution



  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
FUJIFILM CORPORATION
ARIETTA 60
In Commercial Distribution



  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
FUJIFILM CORPORATION
ARIETTA 65
In Commercial Distribution



  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
Prosound Alpha 7
Not in Commercial Distribution

  • 04562122954037 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
Prosound 6
Not in Commercial Distribution

  • 04562122953962 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
ADDW
In Commercial Distribution

  • 04560141949355 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
ADDV
In Commercial Distribution

  • 04560141949348 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
A9RR
In Commercial Distribution

  • 04560141945470 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
A9RP
In Commercial Distribution

  • 04560141945463 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
A8WA
In Commercial Distribution

  • 04560141944534 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
A8AR
In Commercial Distribution

  • 04560141941588 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
A7AP
In Commercial Distribution

  • 04560141940031 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
ADRH
In Commercial Distribution

  • 04560141950092 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
AC7H
In Commercial Distribution

  • 04560141947436 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
AC7J
In Commercial Distribution

  • 04560141947429 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
AC7G
In Commercial Distribution

  • 04560141947412 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
AAK9
In Commercial Distribution

  • 04560141947016 ()


  • General-purpose ultrasound imaging system
No Description
KONICA MINOLTA, INC.
AAEU
In Commercial Distribution

  • 04560141946385 ()


  • General-purpose ultrasound imaging system
The UNEXEF-38G Ultrasound System is a portable,software controlled ultrasound system used to acquire and display high resolution, real time ultrasound data in a variety of modes and clinical settings. This system is Track 3 device that employs an ultrasound probe consisting of ultrasonic transducers arranged in a comb, whereby ultrasound can be generated by supplying electric pulse signals to a group of transducers consisting of multiple adjacent transducers in the single probe.
UNEX CORPORATION
UNEXEF-38G
In Commercial Distribution

  • 04573349040069 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
ARIETTA 750
Not in Commercial Distribution

  • 04562122959841 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
ARIETTA 50
Not in Commercial Distribution

  • 04562122959827 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
ARIETTA 65
Not in Commercial Distribution

  • 04562122959278 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
Aloka Arietta 850
Not in Commercial Distribution

  • 04562122958974 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
ALOKA LISENDO 880
Not in Commercial Distribution

  • 04562122958868 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System wireless
HITACHI, LTD.
ARIETTA Prologue
Not in Commercial Distribution

  • 04562122958738 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
ARIETTA Prologue
Not in Commercial Distribution

  • 04562122958721 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System wireless
HITACHI, LTD.
ARIETTA precision
Not in Commercial Distribution

  • 04562122958707 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
ARIETTA 60
Not in Commercial Distribution

  • 04562122958141 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
ARIETTA 70
Not in Commercial Distribution

  • 04562122958134 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
F37
Not in Commercial Distribution

  • 04562122957878 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
PROSOUND F75
Not in Commercial Distribution

  • 04562122956185 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
Prosound Alpha 6
Not in Commercial Distribution

  • 04562122956062 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
HITACHI, LTD.
Prosound 2
Not in Commercial Distribution

  • 04562122955874 ()


  • General-purpose ultrasound imaging system
1CMR Pro is software that displays, analyses and transfers DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically structure, function and flow in the heart and major vessels using multi-slice, multi-phase, multi-parametric and velocity encoded CMR images. It is compatible with 1.5T and 3T CMR acquisitions
MYCARDIUM AI LIMITED
010002
In Commercial Distribution

  • 05061038730036 ()
1CMR Pro

  • MRI image interpretive software
The EndoSound Vision System (EVS) Software is the Microsoft Windows-based software run on a PC that processes the ultrasound data received from the EVSScanner module and displays the ultrasound image on the PC's monitor.
Endosound, Inc.
5011
In Commercial Distribution

  • 00850050934127 ()
5011

  • General-purpose ultrasound imaging system
Ultrasound Console
ST. JUDE MEDICAL, INC.
H701336
In Commercial Distribution

  • 05415067013361 ()
H701336

  • General-purpose ultrasound imaging system
EndoSound® EVS™ Band Applicator. EndoSound® EVS™ Bands is a disposable, single-use kit used to attach the UTM to compatible endoscopes.
Endosound, Inc.
5012
In Commercial Distribution

  • 10850050934186 ()
  • 00850050934189 ()
  • 00850050934172 ()

  • 19mm tip length
5012

  • General-purpose ultrasound imaging system
EndoSound® EVS™ Bands, is a disposable, single-use kit used to attach the UTM to compatible endoscopes.
Endosound, Inc.
18102
In Commercial Distribution

  • 00850050934141 ()
  • 00850050934158 ()
  • 10850050934155 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
  • 1.25mm wall thickness
5013

  • General-purpose ultrasound imaging system
EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.3mm Wall Thickness: 0.7mm
Endosound, Inc.
5008
In Commercial Distribution

  • 00850050934103 ()
  • 00850050934066 ()

  • Lumen/Inner Diameter: 9.3 Millimeter
  • .7mm wall thickness
5007

  • General-purpose ultrasound imaging system
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