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510(k) Data Aggregation
K Number
K131227Device Name
PADSCAN HD SERIES BLADDER SCANNER
Manufacturer
Date Cleared
2013-07-12
(73 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
CARENOSO TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PadScan HD series Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable battery-operated device. The PadScan HD series Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. The PadScan HD series Bladder Scanner is intended to be used only by qualified medical professionals.
Device Description
The PadScan HD series Bladder Scanner manufactured by Caresono Technology Co., Ltd. provides real-time ultrasound imaging and measuring, and also provides non-invasive volume measurement of the bladder. During image scanning, multiple 2D plane ultrasonic images are acquired in several seconds.
It features:
- Expert operating mode and Easy operating mode. .
- Correct, reliable, fast, and simple operation. ●
- Printouts of ultrasound images with many parameters. ●
- . Portable
- . Combined power supply with AC adapter and a built-in battery.
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