<?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>b6835f20-40d4-4fd7-9f56-677d98009ebf</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2026-06-19</publicVersionDate><devicePublishDate>2016-08-25</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>EMIP18000010</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>MRI Patient Monitoring System Tesla M3</brandName><versionModelNumber>TeslaM3</versionModelNumber><catalogNumber>1800001</catalogNumber><dunsNumber>324416379</dunsNumber><companyName>MIPM Mammendorfer Institut für Physik und Medizin GmbH</companyName><deviceCount>1</deviceCount><deviceDescription>The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.</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>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+49814592090</phone><phoneExtension xsi:nil="true"/><email>info@mipm.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K142032</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61161</gmdnCode><gmdnPTName>MRI-patient physiologic monitoring system</gmdnPTName><gmdnPTDefinition>A mobile assembly of devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of infant to adult intensive care patients during a magnetic resonance imaging (MRI) procedure. It includes an MRI patient monitor, sensors/electrodes (e.g., ECG electrodes, pulse oximetry telemetric transmitter, blood pressure cuff), and typically an additional remote monitor.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MWI</productCode><productCodeName>Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>