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510(k) Data Aggregation
K Number
K140254Device Name
EZONO 4000
Manufacturer
EZONO AG
Date Cleared
2014-02-26
(26 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
EZONO AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Musculo-skeletal (Conventional), Musculo-sketal (Superficial). Invasive diagnosic or therapeutic procedures, Retroperitoneum, Female reproductive system and fetus. Superficial structures & pathologies, Peripheral Vessel, Magnetic Needle guidance
Device Description
The eZono 4000 system is a portable, software-controlled sonography system based on a digital architecture. It supports linear and curvi-linear transducers. The eZono 4000 system has an ergonomic design optimized for stable handling without sharp edges and is very easy to carry with its low weight of 11.5lbs (5.2kg). The robust casing provided with an anti-slip bottom side. The brilliant 12-inch screen with more than 60 million colors makes it possible to acquire and display highresolution, real-time ultrasound images. The eZono Needle Guide System detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. This quides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.
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