<?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>977fd01c-ba4f-48ab-9555-7f6edf680e9e</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2025-11-17</publicVersionDate><devicePublishDate>2020-08-25</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08059307490993</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>RTM 102 HS</brandName><versionModelNumber>1.0/2.0</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>430263475</dunsNumber><companyName>I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA</companyName><deviceCount>1</deviceCount><deviceDescription>Rotating anode X-ray tube for radiography systems</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</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>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>36593</gmdnCode><gmdnPTName>X-ray system tube rotating anode assembly</gmdnPTName><gmdnPTDefinition>A component of an x-ray tube, the rotating anode subassembly provides the means to rotate a disc made of tungsten (W) or an alloy of tungsten at speeds above 3000 revolutions per minute while the x-ray tube is operational. The disc is contained within the vacuum of the glass x-ray tube. The power to effect rotation is provided by a magnetic field produced by stator coils which surround the neck of the x-ray tube outside the glass envelope. This mechanism is used in x-ray tube designs in order to dissipate the heat generated by x-ray tubes and to allow them to withstand the heat generated by large x-ray exposures.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ITY</productCode><productCodeName>Assembly, Tube Housing, X-Ray, Diagnostic</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>