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510(k) Data Aggregation
K Number
K240697Device Name
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
Manufacturer
See-Mode Technologies Pte. Ltd.
Date Cleared
2024-09-09
(179 days)
Product Code
QDQ, LLZ, QIH
Regulation Number
892.2090Why did this record match?
Applicant Name (Manufacturer) :
See-Mode Technologies Pte. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a stand-alone reporting software to assist trained medical professionals in analyzing thyroid ultrasound images of adult (>=22 years old) patients who have been referred for an ultrasound examination.
Output of the device includes regions of interest (ROIs) placed on the thyroid ultrasound images assisting healthcare professionals to localize nodules in thyroid studies. The device also outputs ultrasonographic lexicon-based descriptors based on ACR TI-RADS. The software generates a report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control.
SMART-T may also be used as a structured reporting software for further ultrasound studies. The software includes tools for reading measurements and annotations from the images that can be used for generating a structured report.
Patient management decisions should not be made solely on the basis of analysis by See-Mode Augmented Reporting Tool, Thyroid.
Device Description
See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a stand-alone, web-based image processing and reporting software for localization, characterization and reporting of thyroid ultrasound images.
The software analyzes thyroid ultrasound images and uses machine learning algorithms to extract specific information. The algorithms can identify and localize suspicious soft tissue nodules and also generate lexicon-based descriptors, which are classified according to ACR TI-RADS (composition, echogenicity, shape, margin, and echogenic foci) with a calculated TI-RADS level according to the ACR TI-RADS chart.
SMART-T may also be used as a structured reporting software for further ultrasound studies. The software includes tools for reading measurements and annotations from the images that can be used for generating a structured report.
The software then generates a report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control. Any information within this report can be changed and modified by the clinician if needed during quality control and before finalizing the report.
The software runs on a standard "off-the-shelf" computer and can be accessed within the client web browser to perform the reporting of ultrasound images. Input data and images for the software are acquired through DICOM-compliant ultrasound imaging devices.
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K Number
K201369Device Name
AVA (Augmented Vascular Analysis)
Manufacturer
See-Mode Technologies Pte. Ltd.
Date Cleared
2020-09-16
(117 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
See-Mode Technologies Pte. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
See-Mode AVA (Augmented Vascular Analysis) is a stand-alone, image processing software for analysis, measurement, and reporting of DICOM-compliant vascular ultrasound images obtained from carotid and lower limb arteries. The analysis includes segmentation of vessels walls and measurement of the intima-media thickness (IMT) of the carotid artery in B-Mode images, finding velocities in Doppler images, and reading annotations on the images. The software generates a vascular ultrasound report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control. The client software is designed to run on a standard desktop or laptop computer. See-Mode AVA is intended to be used by trained medical professionals, including but not limited to physicians and medical technicians. The software is not intended to be used as an independent source of medical advice, or to determine or recommend a course of action or treatment for patients.
Device Description
See-Mode AVA (Augmented Vascular Analysis) is a standalone software for analysis and reporting of vascular ultrasound images. There is no dedicated medical equipment required for operation of this software except for an ultrasound machine that is the source of image acquisition. The software runs on a standard off-the-shelf computer and is accessible within a web browser.
See-Mode AVA takes as input DICOM-compliant vascular ultrasound images. The software uses proprietary algorithms for image analysis. including segmentation of vessel walls and measurement of the intima-media thickness (IMT) of the carotid artery in B-Mode images and finding peak systolic and end diastolic velocities (PSV and EDV) from Doppler images. The software generates a vascular ultrasound report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control. Any information within this report must be fully reviewed and approved by a qualified clinician before the vascular ultrasound report is finalized.
See-Mode AVA is not intended to be used as an independent source of analysis and reporting vascular ultrasound images. Any information provided by the software has to be reviewed by a qualified clinician (including sonographers, radiologists, and cardiologists) and can be modified to correct any possible mistakes. The software provides multiple methods for performing quality control and modification of image analysis results. When the vascular ultrasound report is finalized by a qualified clinician, See-Mode AVA exports the report. This report can be used adjunctly with other medical data by a physician to help in the assessment of the cardiovascular health of the patient.
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