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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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
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
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
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: 9.5mm Wall Thickness: 1.25mm
Endosound, Inc.
5010
In Commercial Distribution

  • 00850050934097 ()
  • 00850050934059 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
  • 1.25mm wall thickness
5009

  • 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. UDK Sleeve Size: Inner Diameter: 9mm Wall Thickness: 1mm
Endosound, Inc.
5006
In Commercial Distribution

  • 00850050934080 ()
  • 00850050934073 ()

  • Lumen/Inner Diameter: 9 Millimeter
  • 1mm wall thickness
5005

  • 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. UDK Sleeve Size: Inner Diameter: 10.5mm Wall Thickness: 0.5mm
Endosound, Inc.
5004
In Commercial Distribution

  • 00850050934042 ()
  • 00850050934004 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • .5mm wall thickness
5003

  • General-purpose ultrasound imaging system
The EndoSound Vision System (EVS) Scanner is a small, portable, self-contained module that contains the electronics that perform ultrasound scanning and receiving functions (beamforming).
Endosound, Inc.
5000
In Commercial Distribution

  • 00850050934028 ()
5000

  • General-purpose ultrasound imaging system
The EndoSound Transducer Extension Connector (TEC) includes the electrical connectors and cable between the EVSScanner and the UTM.
Endosound, Inc.
5002
In Commercial Distribution

  • 00850050934011 ()
5002

  • General-purpose ultrasound imaging system
Phased Personal Ultrasound
Vave Health, Inc.
VP3, VA-0116
In Commercial Distribution

  • 00850001977005 ()
VP3

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

  • 04580292771704 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound Scanner
HITACHI, LTD.
HI VISION Ascendus
Not in Commercial Distribution

  • 04580292771612 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
FUJIFILM CORPORATION
ARIETTA x10
In Commercial Distribution

  • 04573596214527 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
FUJIFILM CORPORATION
ARIETTA 650
In Commercial Distribution

  • 04573596214381 ()


  • General-purpose ultrasound imaging system
Ultrasound Diagnostic Scanner
FUJIFILM CORPORATION
Noblus
In Commercial Distribution



  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
FUJIFILM CORPORATION
ALOKA LISENDO 880
In Commercial Distribution



  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
FUJIFILM CORPORATION
F37
In Commercial Distribution



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



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



  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
FUJIFILM CORPORATION
ALOKA ARIETTA 850
In Commercial Distribution



  • General-purpose ultrasound imaging system
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 50
In Commercial Distribution



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



  • 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.
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
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.
ADDW
In Commercial Distribution

  • 04560141949355 ()


  • General-purpose ultrasound imaging system
Imaging system
Conavi Medical Inc
TA-02-0001
In Commercial Distribution

  • 00628055603047 ()


  • General-purpose ultrasound imaging system
Imaging system
Conavi Medical Inc
TA-03-0001
In Commercial Distribution

  • 00628055603030 ()


  • General-purpose ultrasound imaging system
The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
Exact Imaging Inc
1.0
In Commercial Distribution

  • 00628055481027 ()
EV-SYS-120

  • General-purpose ultrasound imaging system
The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
Exact Imaging Inc
1.0
In Commercial Distribution

  • 00628055481010 ()
EV-SYS-220

  • General-purpose ultrasound imaging system
No Description
Laborie Medical Technologies Canada ULC
PRB266
In Commercial Distribution

  • 00627825005562 ()


  • General-purpose ultrasound imaging system
No Description
Laborie Medical Technologies Canada ULC
PRB265
In Commercial Distribution

  • 00627825005555 ()


  • General-purpose ultrasound imaging system
No Description
Laborie Medical Technologies Canada ULC
PRB260
In Commercial Distribution

  • 00627825005548 ()


  • General-purpose ultrasound imaging system
No Description
Laborie Medical Technologies Canada ULC
PRB250
In Commercial Distribution

  • 00627825005531 ()


  • General-purpose ultrasound imaging system
No Description
Laborie Medical Technologies Canada ULC
PRB240
In Commercial Distribution

  • 00627825005524 ()


  • General-purpose ultrasound imaging system
No Description
Laborie Medical Technologies Canada ULC
PRB262
In Commercial Distribution

  • 00627825005517 ()


  • General-purpose ultrasound imaging system
No Description
SAMSUNG MEDISON CO., LTD.
cV7
In Commercial Distribution

  • 08809944969341 ()


  • General-purpose ultrasound imaging system
No Description
SAMSUNG MEDISON CO., LTD.
cV6
In Commercial Distribution

  • 08809944967385 ()


  • General-purpose ultrasound imaging system
No Description
SAMSUNG MEDISON CO., LTD.
USS-HW1ER4E/US
In Commercial Distribution

  • 08809944938262 ()


  • General-purpose ultrasound imaging system
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