<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>99bcab4b-24eb-4a79-866a-66c97d360efb</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2020-11-16</publicVersionDate><devicePublishDate>2016-09-28</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08800019200000</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>NA</brandName><versionModelNumber>EPX-F1600</versionModelNumber><catalogNumber>ECO-ER-CAT-001P</catalogNumber><dunsNumber>688209954</dunsNumber><companyName>ECOTRON</companyName><deviceCount>1</deviceCount><deviceDescription>Input Power: 110V~120V, 50/60Hz
Output Power: 1.6kW
KVP range: 40~90kV
mA range: 12~30mA
mAs range: 0.4~32mAs
X-ray Tube: D-125
Focal Sport: 1.2 x 1.2mm
Target Angle: 16 degrees
Anode heat storage: 50kHU</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>9999999999</phone><phoneExtension xsi:nil="true"/><email>jun1117@ecotron.co.kr</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>37606</gmdnCode><gmdnPTName>Diagnostic x-ray system generator, portable</gmdnPTName><gmdnPTDefinition>An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>IZL</productCode><productCodeName>System, X-Ray, Mobile</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="200"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Height</sizeType><size unit="Millimeter" value="190"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="355"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Weight</sizeType><size unit="Kilogram" value="13"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="95"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="60"/><storageHandlingLow unit="Degrees Celsius" value="-25"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="75"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="35"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="40"/><storageHandlingLow unit="Degrees Celsius" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>