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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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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

PowerLook AI Mammo Container 1.0.0 Blackford - 00850008977534

No Description
Icad, Inc.
DSC036-01
In Commercial Distribution

  • 00850008977534 ()


  • Radiology DICOM image processing application software

16 Ch AI BREAST COIL 1.5T - 04260487680034

No Description
RAPID Biomedical GmbH
10185781 02
In Commercial Distribution

  • 04260487680034 ()


  • MRI system coil, radio-frequency

K-ASSAY® Apo AI / B Control - 00816426021648

For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
K310C-4M
In Commercial Distribution

  • 00816426021648 ()
K310C-4M

  • Multiple apolipoprotein IVD, control

K-ASSAY® Apo AI / B Control - 00816426021631

For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
K310C-2M
Not in Commercial Distribution

  • 00816426021631 ()
K310C-2M

  • Multiple apolipoprotein IVD, control

QUANTUM™ CT Overlay - 10841962109045

QUANTUM CT for Somatom Emotion Duo, Esprit +, CT For 217cm long cradle
Qfix
RT-4550SS2
In Commercial Distribution

  • 10841962109045 ()

  • Length: 217 Centimeter
RT-4550SS2

  • Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay - 10841962108888

QUANTUM CT Overlay for GE HiSpeed CT For 219 cm long cradle
Qfix
RT-4550GEH
In Commercial Distribution

  • 10841962108888 ()

  • Length: 219 Centimeter
RT-4550GEH

  • Indexed-immobilization patient positioning system

METZENBAUM SCISSORS - 00192896098039

METZENBAUM SCISSORS CURVED TUNGSTEN CARBIDE SERRATED BLADE POWER CUT GOLD/BLACK QUANTUM
SONTEC INSTRUMENTS, INC.
1200-510Q
In Commercial Distribution

  • 00192896098039 ()

  • Length: 5.75 Inch
1200-510Q

  • General-purpose surgical scissors, reusable

METZENBAUM SCISSORS - 00192896098022

METZENBAUM SCISSORS STRAIGHT TUNGSTEN CARBIDE SERRATED BLADE POWER CUT GOLD/BLACK QUANTUM
SONTEC INSTRUMENTS, INC.
1200-505Q
In Commercial Distribution

  • 00192896098022 ()

  • Length: 5.75 Inch
1200-505Q

  • General-purpose surgical scissors, reusable
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