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510(k) Data Aggregation
K Number
K160279Device Name
ANYVIEW-500R Fluoroscopic Mobile X-Ray System
Manufacturer
ECOTRON CO.,LTD
Date Cleared
2016-10-14
(255 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ECOTRON CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Anyview-500R fluoroscopic mobile x-ray system is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.
This system can be applied in emergency room, operation room, cast room or etc. of hospital.
Device Description
This device is a mobile x-ray fluoroscopic imaging system used by radiation experts. This device is a fluoroscopic imaging system to visualize human body's anatomical structure using a principle that x-ray qenerates hypophonesis difference when penetrating human body depending on tissue's density and thickness. The device is composed of main body, x-ray generating equipment (x-ray controller, high voltage generator, x-ray tube, motortype collimator), image collecting equipment (Image Intensifier, CCD Camera) and digital imaging system (cart including computer and monitor). The product's arm is mobile and rotatable in X, Y and Z axes, which facilitates use of x-ray in every direction.
ANYVIEW imaging software is a Digital Imaging System (DIS) designed for C-arm, Anyview-500R. ANYVIEW imaging software provides useful functions to manage X-ray images obtained from Anyview 500R C-arm.
ANYVIEW imaging software provides various image tools. One of the most noticeable features is that the C-arm images taken during an exam are stored in the database for further review. Image data is integrated with the patient information in DICOM(OPTION) compatible format which allows compatibility with existing DICOM and PACS system. All these features are available in a single application program, ANYVIEW.
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K Number
K151038Device Name
EPX-Series Mobile X-ray System
Manufacturer
ECOTRON CO.,LTD
Date Cleared
2015-07-24
(95 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
ECOTRON CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product, diagnostic X-ray system, is radiation medical equipment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.
Device Description
This product, portable X-ray generator, is radiation medical equipment which can only be used by professional radiologists. It controls and marks Xray dose within the range of X-ray exposure limited by hardware. Also it uses algorithm of X-ray output for processing and control. This portable Xray generator requires equipment for X-ray images. Small in size, this product is convenient to carry with, and suitable for being moved around. The main body used with a stand. And when attached to a stand, it is easy to adjust positioning for medical imaging.
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