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AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 04719875621000 ()
- 14719875621007 ()
UT-0222
- Ultrasound imaging system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2258
Not in Commercial Distribution
- 04953170390616 ()
- Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2528
In Commercial Distribution
- 04953170435201 ()
- Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2051
Not in Commercial Distribution
- 04953170328985 ()
- Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2370
In Commercial Distribution
- 04953170406461 ()
- Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2139
Not in Commercial Distribution
- 04953170363016 ()
- Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2088
Not in Commercial Distribution
- 04953170352881 ()
- Operating room audiovisual data/device management system application software
U.S. IFU Manual and CDs, BioPlex 2200 HIV Ag-Ab IFU 665-3465A
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution
- 00847865001281 ()
- 1 Each
665-3465A
- Laboratory instrument/analyser application software IVD
BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications.
Healthcare professionals are the intended operators of this device.
The Device is intended for use on patients who are 18 years of age or older.
The Device is not intended for critical care.
BIOINTELLISENSE, INC.
SW-BDB
In Commercial Distribution
- 00850005949466 ()
N/A
- Clinical management support software
suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution
- 00850001088015 ()
- MRI system application software