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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
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
ALLIGATOR GRASPING FORCEPS DELICATE SHAFT SMALL JAW LOCK 3.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-328SQ
In Commercial Distribution
- 00192896091467 ()
- Length: 3.5 Inch
1100-328SQ
- Surgical soft-tissue manipulation forceps, alligator, reusable
SONTEC OLSEN-HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP 6.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-108Q
In Commercial Distribution
- 00192896088528 ()
- Length: 6.5 Inch
1100-108Q
- Suturing needle holder, reusable
BROWN ADSON TISSUE FORCEPS SERRATED HANDLE 7 X 7 TEETH QUANTUM
SONTEC INSTRUMENTS, INC.
136-688SQ
In Commercial Distribution
- 00192896105447 ()
- Length: 4.75 Inch
- Surgical soft-tissue manipulation forceps, tweezers-like, reusable
STEVENS TENOTOMY SCISSORS POWER CUT GOLD SHORT TIP STRAIGHT BLUNT QUANTUM
SONTEC INSTRUMENTS, INC.
1200-050Q
In Commercial Distribution
- 00192896104082 ()
- Length: 4.125 Inch
- Nasal scissors
LARYNGOSCOPY FORCEPS RIGHT CURVED HEART SHAPED TIP CONICAL TUBE SHAFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-256Q
In Commercial Distribution
- 00192896095632 ()
- 2 Millimeter Shaft
- Length: 9 Inch
1301-256Q
- Flexible endoscopic biopsy forceps, reusable
MICRO BIOPSY FORCEPS DELICATE STRAIGHT OVAL CUP BLACK ANODIZE COATED QUANTUM
SONTEC INSTRUMENTS, INC.
469-070BQ
In Commercial Distribution
- 00192896100923 ()
- Length: 3 Inch
- 1.2 x 0.9 Millimeters Cup
- Rigid endoscopic biopsy forceps, reusable
MAYO HEGAR NEEDLE HOLDER LEFT HANDED TUNGSTEN CARBIDE SERRATED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
132-118LQ
In Commercial Distribution
- 00192896100732 ()
- Length: 7.25 Inch
- Suturing needle holder, reusable