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510(k) Data Aggregation
K Number
K182213Device Name
QT Ultrasound Breast Scanner - 1
Manufacturer
Date Cleared
2018-09-14
(30 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
QT Ultrasound LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The QT Ultrasound Breast Scanner - 1 is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient's breast. The device is not intended to be used as a replacement for screening mammography.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (Breast) - Reflection, Transmission (Speed of Sound). QT Ultrasound Breast Scanner-1 is intended for ultrasonic breast exams.
Device Description
The QT Ultrasound Breast Scanner - 1 is an automated software-controlled ultrasonic imaging system that performs a standardized scan of the whole breast. The OT Ultrasound Breast Scanner - 1 is comprised of a Patient Scanning System, Operator Console and Viewer Console.
The Patient Scanning System consists of a patient support table, scan tank, water management system, ultrasound transducer arrays and all associated image processing electronics. The scan tank is centered below a patient's breast and contains the ultrasound transducer arrays. The transducer arrays include a set of three reflection transducers that transmit pulsed ultrasound plane waves into targeted tissues using the water bath in the scan tank as a coupling medium. An additional transmitter and receiver array pair collect the ultrasound energy to provide speed of sound values.
During scanning, a patient lies prone on the examination table with the breast suspended in a warm water bath maintained near skin temperature. Images are automatically acquired on a pendant breast positioned with the nipple as a point of reference. The transducer arrays rotate about a vertical axis to circle the breast in the coronal plane. The array is then translated vertically, and the scanning process is repeated until the entire breast is scanned, allowing B-scan images to be constructively combined into tomographic, speed of sound and reflection ultrasound images.
The QT Ultrasound Breast Scanner – 1 outputs the images to the QTviewer™ which allows the images to be stored until they are reviewed on a Viewer Console. Coronal, axial and sagittal images are generated for review by the radiologist. Speed of sound images may be queried by the Probe and Region of Interest (ROI) tools provided in the Viewer Console. These tools provide speed of sound values in meters/sec. to aid in diagnostic evaluation of the breast.
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K Number
K162372Device Name
QT Ultrasound Breast Scanner-1
Manufacturer
Date Cleared
2017-06-06
(286 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
QT ULTRASOUND LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The QT Ultrasound Breast Scanner-1 is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient's breast. The device is not intended to be used as a replacement for screening mammography.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Small Organ (Breast) - Reflection, Transmission (Speed of Sound)
QT Ultrasound Breast Scanner-1 is intended for ultrasonic breast exams
Device Description
The QT Ultrasound Breast Scanner-1 is an automated software-controlled ultrasonic imaging system that performs a standardized scan of the whole breast. The OT Ultrasound Breast Scanner-1 is comprised of a Patient Scanning System, Operator Console and Viewer Console.
The Patient Scanning System consists of a patient support table, scan tank, water management system, ultrasound transducer arrays and all associated image processing electronics. The scan tank is centered below a patient's breast and contains the ultrasound transducer arrays. The transducer arrays include a set of three reflection transducers that transmit pulsed ultrasound plane waves into targeted tissues using the water bath in the scan tank as coupling medium. An additional transmitter and receiver array pair collect the ultrasound energy to provide speed of sound values.
During scanning, a patient lies prone on the examination table with the breast suspended in a warm water bath maintained near skin temperature. Images are automatically acquired on a pendant breast positioned with the nipple as a point of reference. The transducer arrays rotate about a vertical axis to circle the breast in the coronal plane. The array is then translated vertically and the scanning process is repeated until the entire breast is scanned, allowing B-scan images to be constructively combined into tomographic, speed of sound and reflection ultrasound images.
The QT Ultrasound Breast Scanner-1 outputs the images to the QTviewer which allows the images to be stored until they are reviewed on a Viewer Console. Coronal, axial and sagittal images are generated for review by the radiologist. Speed of sound images may be queried by the Probe and Region of Interest (ROI) tools provided in the Viewer Console. These tools provide speed of sound values in meters/sec. to aid in diagnostic evaluation of the breast.
Ask a Question
Ask a specific question about this device
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