<?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>38514f2a-db76-4bba-a6a7-69ef10634429</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>7</publicVersionNumber><publicVersionDate>2023-07-10</publicVersionDate><devicePublishDate>2017-04-25</devicePublishDate><deviceCommDistributionEndDate>2020-10-30</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00817740020522</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>BIONIX RADIATION THERAPY</brandName><versionModelNumber>HNRT-7664</versionModelNumber><catalogNumber>HNRT-7664</catalogNumber><dunsNumber>080397923</dunsNumber><companyName>Bionix Radiation Therapy, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>CARBON FIBER 45 DEGREE ATTACHMENT</deviceDescription><DMExempt>true</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)624-6649</phone><phoneExtension xsi:nil="true"/><email>xxx@xxx.xxx</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>40902</gmdnCode><gmdnPTName>Radiological whole-body positioner</gmdnPTName><gmdnPTDefinition>A device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient&apos;s whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>IYE</productCode><productCodeName>Accelerator, linear, medical</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>