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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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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

X-CUBE 60 - 08800013545008

The X-CUBE 60 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 60 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE 60
In Commercial Distribution

  • 08800013545008 ()


  • General-purpose ultrasound imaging system

X-CUBE 50 - 08800013544001

The X-CUBE 50 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 50 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE 50
In Commercial Distribution

  • 08800013544001 ()


  • General-purpose ultrasound imaging system

X-CUBE i9 - 08800013543004

The X-CUBE i9 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo- skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph. (Cardiac); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode. The X-CUBE i9 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE i9
In Commercial Distribution

  • 08800013543004 ()


  • General-purpose ultrasound imaging system

X-CUBE i8 - 08800013542007

The X-CUBE i8 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo- skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph. (Cardiac); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode. The X-CUBE i8 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE i8
In Commercial Distribution

  • 08800013542007 ()


  • General-purpose ultrasound imaging system

X-CUBE 90 - 08800013541000

The X-CUBE 90 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 90 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE 90
In Commercial Distribution

  • 08800013541000 ()


  • General-purpose ultrasound imaging system

X-CUBE 70 - 08800013540003

The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 70 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE 70
In Commercial Distribution

  • 08800013540003 ()


  • General-purpose ultrasound imaging system

minisono - 08800013531001

No Description
Alpinion Medical Systems Co., Ltd.
minisono C1-6
In Commercial Distribution

  • 08800013531001 ()


  • General-purpose ultrasound imaging system

minisono - 08800013530004

No Description
Alpinion Medical Systems Co., Ltd.
minisono L3-12
In Commercial Distribution

  • 08800013530004 ()


  • General-purpose ultrasound imaging system

E-CUBE - 08800013528001

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 8
In Commercial Distribution

  • 08800013528001 ()


  • General-purpose ultrasound imaging system

E-CUBE - 08800013527004

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE inno
In Commercial Distribution

  • 08800013527004 ()


  • General-purpose ultrasound imaging system

E-CUBE - 08800013526007

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE i7
In Commercial Distribution

  • 08800013526007 ()


  • General-purpose ultrasound imaging system

E-CUBE - 08800013525000

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 15
In Commercial Distribution

  • 08800013525000 ()


  • General-purpose ultrasound imaging system

E-CUBE - 08800013524003

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 12
In Commercial Distribution

  • 08800013524003 ()


  • General-purpose ultrasound imaging system

E-CUBE - 08800013523006

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 11
In Commercial Distribution

  • 08800013523006 ()


  • General-purpose ultrasound imaging system

E-CUBE - 08800013522009

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 9
In Commercial Distribution

  • 08800013522009 ()


  • General-purpose ultrasound imaging system

E-CUBE - 08800013521002

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 7
In Commercial Distribution

  • 08800013521002 ()


  • General-purpose ultrasound imaging system

E-CUBE - 08800013520005

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 5
In Commercial Distribution

  • 08800013520005 ()


  • 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

QP-Prostate® CAD - 08437021468168

QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level).
QUIBIM SOCIEDAD LIMITADA.
1.1
In Commercial Distribution

  • 08437021468168 ()


  • MRI image interpretive software

QP-Prostate® CAD - 08437021468120

QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level).
QUIBIM SOCIEDAD LIMITADA.
1.0
In Commercial Distribution

  • 08437021468120 ()


  • MRI image interpretive software

Enovare - 08638750003013

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

  • 08638750003013 ()


  • General-purpose ultrasound imaging system

SonoSite SII - 00841517101411

No Description
FUJIFILM SONOSITE, INC.
P20883-12
In Commercial Distribution

  • 00841517101411 ()


  • General-purpose ultrasound imaging system

SonoSite Edge II - 00841517101404

Diagnostic ultrasound system
FUJIFILM SONOSITE, INC.
P20680-11
In Commercial Distribution

  • 00841517101404 ()


  • General-purpose ultrasound imaging system

SonoSite SII - 00841517101398

No Description
FUJIFILM SONOSITE, INC.
P20500-12
In Commercial Distribution

  • 00841517101398 ()


  • General-purpose ultrasound imaging system

SonoSite Edge - 00841517101381

No Description
FUJIFILM SONOSITE, INC.
P15000-19R
In Commercial Distribution

  • 00841517101381 ()
P15000

  • General-purpose ultrasound imaging system

SonoSite Edge - 00841517101374

No Description
FUJIFILM SONOSITE, INC.
P15000-19
In Commercial Distribution

  • 00841517101374 ()
P15000

  • General-purpose ultrasound imaging system

SonoSite NanoMaxx - 00841517101336

No Description
FUJIFILM SONOSITE, INC.
P11111-46R
In Commercial Distribution

  • 00841517101336 ()
P11111

  • General-purpose ultrasound imaging system

SonoSite NanoMaxx - 00841517101329

No Description
FUJIFILM SONOSITE, INC.
P11111-46
In Commercial Distribution

  • 00841517101329 ()
P11111

  • General-purpose ultrasound imaging system

SonoSite S-Series - 00841517101312

No Description
FUJIFILM SONOSITE, INC.
P09417-69R
In Commercial Distribution

  • 00841517101312 ()
P09417

  • General-purpose ultrasound imaging system

SonoSite S-Series - 00841517101305

No Description
FUJIFILM SONOSITE, INC.
P09417-69
In Commercial Distribution

  • 00841517101305 ()
P09417

  • General-purpose ultrasound imaging system
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