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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) 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
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
No Description
RAPID Biomedical GmbH
10185781 02
In Commercial Distribution

  • 04260487680034 ()


  • MRI system coil, radio-frequency
No Description
Icad, Inc.
DSC036-01
In Commercial Distribution

  • 00850008977534 ()


  • Radiology DICOM image processing application software
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
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
Stratte Needle Holder Right Angled Tungsten Carbide Serrated Tip Light Weight Quantum
SONTEC INSTRUMENTS, INC.
2300-489RQ
In Commercial Distribution

  • 00192896117495 ()

  • Length: 10 Inch
2300-489RQ

  • Suturing needle holder, reusable
Knight Nasal Scissors Serrated Power Cut Gold Right Curved 7.0 Inches Quantum
SONTEC INSTRUMENTS, INC.
475-306Q
In Commercial Distribution

  • 00192896111677 ()

  • Length: 7 Inch


  • Nasal scissors
Stevens Saberback Tenotomy Scissors Pointed Tips Tungsten Carbide Power Cut Curved Quantum
SONTEC INSTRUMENTS, INC.
2400-367Q
In Commercial Distribution

  • 00192896109759 ()

  • Length: 4.5 Inch


  • Tenotome
Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Oval Straight Quantum
SONTEC INSTRUMENTS, INC.
1301-234Q
In Commercial Distribution

  • 00192896107700 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable
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