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The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.3.0
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
V0.1.4
In Commercial Distribution
- 00850012642015 ()
- MRI image interpretive software
AI SaMD for prostate cancer.
Avenda Health, Inc.
V0.1.4
In Commercial Distribution
- 00850012642008 ()
- MRI image interpretive software
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
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