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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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Cologuard Test Definition v1.6 - 00858637005826

No Description
EXACT SCIENCES CORPORATION
1.6
Not in Commercial Distribution

  • 00858637005826 ()


  • Laboratory instrument/analyser application software IVD

STARlet Interface - 00858637005413

No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005413 ()


  • Laboratory instrument/analyser application software IVD

Analytical Client - 00858637005406

No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005406 ()


  • Laboratory instrument/analyser application software IVD

Analytical Server - 00858637005390

No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005390 ()


  • Laboratory instrument/analyser application software IVD

Cologuard Test Definition v1.4 - 00858637005352

No Description
EXACT SCIENCES CORPORATION
1.4
Not in Commercial Distribution

  • 00858637005352 ()


  • Laboratory instrument/analyser application software IVD

Cycler Control - 00858637005321

No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005321 ()


  • Laboratory instrument/analyser application software IVD

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586341

No Description
CAPTION HEALTH, INC.
Alastor
Not in Commercial Distribution

  • 00860003586341 ()


  • Ultrasound imaging system application software

Caption Guidance - 00860003586334

The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
CAPTION HEALTH, INC.
Apollo
Not in Commercial Distribution

  • 00860003586334 ()
511-00021

  • Ultrasound imaging system application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586310

Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound. The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
Adonis
Not in Commercial Distribution

511-00019

  • Ultrasound imaging system application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586303

The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
0.10, 0.11, 1.1, 1.2, 1.3, 1.4
Not in Commercial Distribution

  • 00860003586303 ()
511-00003

  • Ultrasound imaging system application software
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