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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
In Commercial Distribution
- 00860003586334 ()
511-00021
- Ultrasound imaging system application software
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
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
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.
Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution
- 00860002545707 ()
- Ultrasound imaging system application software
No Description
CORTECHS LABS INC
NQ BT
In Commercial Distribution
- 00860000004824 ()
- MRI system application software
GRAFT SIZER
STRYKER CORPORATION
2000-004-051
In Commercial Distribution
- 04546540790989 ()
2000-004-051
- Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 8MM
STRYKER CORPORATION
234-020-087
In Commercial Distribution
- 04546540755889 ()
- Lumen/Inner Diameter: 8.0 Millimeter
234-020-087
- Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 7MM
STRYKER CORPORATION
234-020-086
In Commercial Distribution
- 04546540755872 ()
- Lumen/Inner Diameter: 7.0 Millimeter
234-020-086
- Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 6MM
STRYKER CORPORATION
234-020-085
In Commercial Distribution
- 04546540755865 ()
- Lumen/Inner Diameter: 6.0 Millimeter
234-020-085
- Ligament graft sizer, noninvasive
DRILL GUIDE/GRAFT SIZER, MODULAR ACL WORKSTATION
STRYKER CORPORATION
234-010-517
In Commercial Distribution
- 04546540755124 ()
234-010-517
- Ligament graft sizer, noninvasive
13MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-514
In Commercial Distribution
- 04546540755094 ()
- Lumen/Inner Diameter: 13.0 Millimeter
234-010-514
- Ligament graft sizer, noninvasive
12.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-513
In Commercial Distribution
- 04546540755087 ()
- Lumen/Inner Diameter: 12.5 Millimeter
234-010-513
- Ligament graft sizer, noninvasive
11.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-512
In Commercial Distribution
- 04546540755070 ()
- Lumen/Inner Diameter: 11.5 Millimeter
234-010-512
- Ligament graft sizer, noninvasive
10.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-511
In Commercial Distribution
- 04546540755063 ()
- Lumen/Inner Diameter: 10.5 Millimeter
234-010-511
- Ligament graft sizer, noninvasive
9.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-510
In Commercial Distribution
- 04546540755056 ()
- Lumen/Inner Diameter: 9.5 Millimeter
234-010-510
- Ligament graft sizer, noninvasive
8.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-509
In Commercial Distribution
- 04546540755049 ()
- Lumen/Inner Diameter: 8.5 Millimeter
234-010-509
- Ligament graft sizer, noninvasive
7.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-508
In Commercial Distribution
- 04546540755032 ()
- Lumen/Inner Diameter: 7.5 Millimeter
234-010-508
- Ligament graft sizer, noninvasive
6.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-507
In Commercial Distribution
- 04546540755025 ()
- Lumen/Inner Diameter: 6.5 Millimeter
234-010-507
- Ligament graft sizer, noninvasive
12MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-005
In Commercial Distribution
- 04546540754417 ()
- Lumen/Inner Diameter: 12.0 Millimeter
234-010-005
- Ligament graft sizer, noninvasive
11MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-004
In Commercial Distribution
- 04546540754400 ()
- Lumen/Inner Diameter: 11.0 Millimeter
234-010-004
- Ligament graft sizer, noninvasive