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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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Percutaneous Micro-Introducer Kit - 00886333215027

5F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497812
In Commercial Distribution

  • 10886333215024 ()
  • 00886333215027 ()
  • 20886333215021 ()

  • 5F
497812

  • Magnetocardiography system

Percutaneous Micro-Introducer Kit - 00886333215010

4F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497811
Not in Commercial Distribution

  • 10886333215017 ()
  • 00886333215010 ()
  • 20886333215014 ()

  • 4F
497811

  • Magnetocardiography system

Percutaneous Micro-Introducer Kit - 00886333215003

5F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497802
In Commercial Distribution

  • 10886333215000 ()
  • 00886333215003 ()
  • 20886333215007 ()

  • 5F
497802

  • Magnetocardiography system

Percutaneous Micro-Introducer Kit - 00886333214990

4F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497801
In Commercial Distribution

  • 10886333214997 ()
  • 00886333214990 ()
  • 20886333214994 ()

  • 4F
497801

  • Magnetocardiography system

Overjet Image Enhancement Assist - 00860005586370

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586370 ()


  • Dental x-ray image interpretive software

Overjet Caries Assist-Pediatric - 00860005586363

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586363 ()


  • Dental x-ray image interpretive software

Overjet Charting Assist - 00860005586356

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586356 ()


  • Dental x-ray image interpretive software

Overjet Periapical Radiolucency Assist - 00860005586332

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586332 ()


  • Dental x-ray image interpretive software

Overjet Calculus Assist - 00860005586325

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586325 ()


  • Dental x-ray image interpretive software

Overjet Caries Assist - 00860005586318

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586318 ()


  • Dental x-ray image interpretive software

Overjet Dental Assist - 00860005586301

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586301 ()


  • Dental x-ray image interpretive software

Velmeni for Dentists - 00860010893203

No Description
Velmeni Inc.
1.0
In Commercial Distribution

  • 00860010893203 ()
V4D

  • Dental x-ray image interpretive software

Videa Caries Assist - 00860009836808

Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.
Videahealth, Inc.
VCA01B
In Commercial Distribution

  • 00860009836808 ()


  • Dental x-ray image interpretive software

Videa Dental Assist - 00860009836822

Update: Now commercialized under the brand name 'Videa Dental AI'. Videa Dental AI is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize suspect dental finding, historical treatment and normal anatomy features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older.
Videahealth, Inc.
VDA01BPN
In Commercial Distribution

  • 00860009836822 ()


  • Dental x-ray image interpretive software

Videa Perio Assist - 00860009836815

Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages.
Videahealth, Inc.
VPA01BP
In Commercial Distribution

  • 00860009836815 ()


  • Dental x-ray image interpretive software

Videa Caries Assist - 00196852162192

Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.
Videahealth, Inc.
VCA01B
Not in Commercial Distribution

  • 00196852162192 ()


  • Dental x-ray image interpretive software

Unfold AI - 00850012642015

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

Unfold AI - 00850012642084

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.
v0.9.0
In Commercial Distribution

  • 00850012642084 ()


  • MRI image interpretive software

Unfold AI - 00850012642077

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.
v0.8.0
In Commercial Distribution

  • 00850012642077 ()


  • MRI image interpretive software

Unfold AI - 00850012642060

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.
v0.7.0
In Commercial Distribution

  • 00850012642060 ()


  • MRI image interpretive software
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