<?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>5e154c88-f50c-4a1c-85ed-6b7cdd312449</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2016-09-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>18033837190018</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08033837190011</containsDINumber><pkgQuantity>1</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>X006528</pkgType></identifier><identifier><deviceId>08033837190011</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>GIOTTO IMAGE 3DL</brandName><versionModelNumber>GIOTTO IMAGE_20&apos;&apos; 3Mpixel</versionModelNumber><catalogNumber>6909</catalogNumber><dunsNumber>429113525</dunsNumber><companyName>I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL</companyName><deviceCount>1</deviceCount><deviceDescription>GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy.</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>true</rx><otc>false</otc><contacts/><premarketSubmissions><premarketSubmission><submissionNumber>K111434</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>36513</gmdnCode><gmdnPTName>Mammographic x-ray system stereotactic unit</gmdnPTName><gmdnPTDefinition>A device that can only fulfil its purpose when used together with and enhance the function of a diagnostic mammographic x-ray system. It is used to take two pictures of a breast from two different angles. On the basis of this stereoscopic picture set, it is possible to determine the exact position of a lesion in the breast and a cytological sample of this will be taken. This device or technique may be built-in to some diagnostic x-ray systems for mammography.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MUE</productCode><productCodeName>Full Field Digital,System,X-Ray,Mammographic</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Height</sizeType><size unit="Millimeter" value="2240"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Depth</sizeType><size unit="Millimeter" value="1140"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="1150"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="70"/><storageHandlingLow unit="Degrees Celsius" value="-20"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>