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510(k) Data Aggregation
K Number
K190995Device Name
ExactVu High Resolution Micro-Ultrasound System
Manufacturer
Date Cleared
2019-05-10
(24 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Exact Imaging, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Exact Vu micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use (clinical applications) are:
• Small Organ
• Transrectal
• Abdominal
The system may be used with patients of all ages, but is not designed for pediatric or fetal use.
The system is contraindicated for direct cardiac application and for ophthalmic use or any application that causes the acoustic beam to pass through the eye.
Device Description
The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System comprises transducers responsible for ultrasound signal generation and recording, needle guides and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
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