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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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SMC12-3 Gen II® - 03760193600070

Mircoconvex Probe SMC12-3 Gen II®
Supersonic Imagine, Inc.
SSIP92097
In Commercial Distribution

  • 03760193600070 ()

  • Length: 250 Centimeter
SSIP92097

  • General-purpose ultrasound imaging system

SL10-2 Gen II® - 03760193600063

Linear Probe SL10-2 Gen II®
Supersonic Imagine, Inc.
SSIP92085
In Commercial Distribution

  • 03760193600063 ()

  • Length: 250 Centimeter
SSIP92085

  • General-purpose ultrasound imaging system

SE12-3 Gen II® - 03760193600056

Endo Probe SE12-3 Gen II®
Supersonic Imagine, Inc.
SSIP92068
In Commercial Distribution

  • 03760193600056 ()

  • Length: 250 Centimeter
SSIP92068

  • General-purpose ultrasound imaging system

AIXPLORER V - 03760193600049

AIXPLORER V
Supersonic Imagine, Inc.
SSIP92188
In Commercial Distribution

  • 03760193600049 ()

  • Length: 250 Centimeter
SSIP92188

  • General-purpose ultrasound imaging system

SC6-1 Gen II® - 03760193600032

Curved Probe SC6-1 Gen II®
Supersonic Imagine, Inc.
SSIP92030
In Commercial Distribution

  • 03760193600032 ()

  • Length: 250 Centimeter
SSIP92030

  • General-purpose ultrasound imaging system

SL15-4 Gen II® - 03760193600025

Linear Probe SL15-4 Gen II®
Supersonic Imagine, Inc.
SSIP92002
In Commercial Distribution

  • 03760193600025 ()

  • Length: 250 Centimeter
SSIP92002

  • General-purpose ultrasound imaging system

Aixplorer® - 03760193600018

Imaging Ultrasound Diagnostic System
Supersonic Imagine, Inc.
SSIP92029
In Commercial Distribution

  • 03760193600018 ()

  • Length: 250 Centimeter
SSIP92029

  • General-purpose ultrasound imaging system

SEV12-3 GEN II® - 03760193600001

Endocavitary Probe SEV12-3 GEN II
Supersonic Imagine, Inc.
SSIP93189
In Commercial Distribution

  • 03760193600001 ()

  • Length: 250 Centimeter
SSIP93189

  • General-purpose ultrasound imaging system

Enovare - 08638750003013

diagnostic ultrasound system
OREON TECHNOLOGIES INC.
4001001
Not in Commercial Distribution

  • 08638750003013 ()


  • General-purpose ultrasound imaging system

Portascan+ - 08717775956051

No Description
Medical Measurement Systems B.V.
Portascan+
In Commercial Distribution

  • 08717775956051 ()


  • General-purpose ultrasound imaging system

3D Side Fire Endocavity Probe - 03665134000844

Compact PERINE Probe. Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00-2
In Commercial Distribution

  • 03665134000851 ()
  • 03665134000844 ()
K3DEL00-2

  • General-purpose ultrasound imaging system

TRINITY - 03665134000684

A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
KOELIS
KURO-3000-3
In Commercial Distribution

  • 03665134000691 ()
  • 03665134000684 ()
  • 03665134000707 ()


  • General-purpose ultrasound imaging system

2D Linear Probe - 03665134000103

Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm
KOELIS
K2DLN00
In Commercial Distribution

  • 03665134000530 ()
  • 03665134000103 ()


  • General-purpose ultrasound imaging system

2D Abdominal Probe - 03665134000097

Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm
KOELIS
K2DAB00
In Commercial Distribution

  • 03665134000523 ()
  • 03665134000097 ()


  • General-purpose ultrasound imaging system

3D Side-Fire Endocavity Probe - 03665134000080

Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00
In Commercial Distribution

  • 03665134000516 ()
  • 03665134000080 ()


  • General-purpose ultrasound imaging system

3D End-Fire Endocavity Probe - 03665134000073

Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm
KOELIS
K3DEC00-2
In Commercial Distribution

  • 03665134000509 ()
  • 03665134000073 ()


  • General-purpose ultrasound imaging system

TRINITY - 03665134000035

A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart, Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
KOELIS
KURO3000-2
Not in Commercial Distribution

  • 03665134000547 ()
  • 03665134000035 ()
  • 03665134000554 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362400024

SonixONE Ultrasound System
ANALOGIC CORPORATION
24.000.100
Not in Commercial Distribution

  • 08294362400024 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362400000

SonixTABLET Ultrasound System
ANALOGIC CORPORATION
24.000.000
Not in Commercial Distribution

  • 08294362400000 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362200020

SonixSP Q+Ultrasound System
ANALOGIC CORPORATION
22.000.000-02
Not in Commercial Distribution

  • 08294362200020 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362200006

SonixSP Ultrasound System
ANALOGIC CORPORATION
22.000.000
Not in Commercial Distribution

  • 08294362200006 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362100023

SonixOP Q+ Ultrasound System
ANALOGIC CORPORATION
21.000.000-02
Not in Commercial Distribution

  • 08294362100023 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362100009

SonixOP Ultrasound System
ANALOGIC CORPORATION
21.000.000
Not in Commercial Distribution

  • 08294362100009 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362000026

SonixMDP Q+ Ultrasound System
ANALOGIC CORPORATION
20.000.000-02
Not in Commercial Distribution

  • 08294362000026 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362000002

SonixMDP Ultrasound System
ANALOGIC CORPORATION
20.000.000
Not in Commercial Distribution

  • 08294362000002 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294361800023

SonixTOUCH Q+ Ultrasound System
ANALOGIC CORPORATION
18.000.000-02
Not in Commercial Distribution

  • 08294361800023 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294361800009

SonixTOUCH Ultrasound System
ANALOGIC CORPORATION
18.000.000
Not in Commercial Distribution

  • 08294361800009 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294360246341

SonixONE Cart
ANALOGIC CORPORATION
00.024.634
Not in Commercial Distribution

  • 08294360246341 ()


  • General-purpose ultrasound imaging system

MyLabE85 - 08056304455642

No Description
ESAOTE SPA
100645084
In Commercial Distribution

  • 08056304455642 ()


  • General-purpose ultrasound imaging system

MyLabE80 - 08056304455635

No Description
ESAOTE SPA
100645083
In Commercial Distribution

  • 08056304455635 ()


  • General-purpose ultrasound imaging system
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