{"publicDeviceRecordKey":"feb9901d-f7ad-425e-bcb3-d6b94df338b1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-05-15T00:00:00.000Z","devicePublishDate":"2017-04-14T00:00:00.000Z","deviceCommDistributionEndDate":"2025-05-14T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08718755000429","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Claymount","versionModelNumber":"50129-21-OEM","catalogNumber":null,"dunsNumber":"413223942","companyName":"Varex Imaging Nederland B.V.","deviceCount":1,"deviceDescription":"x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator)\nThis is a device out of the Optica 30 series","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"42252","gmdnPTName":"Manual-aperture-control diagnostic x-ray system collimator, motorized","gmdnPTDefinition":"A standard, diagnostic x-ray beam-limiting and shaping device with a motorized shutter/length adjustment mechanism that requires the operator to manually adjust the collimator shutters or length of the cone prior to an exposure in order to match the size and shape of the x-ray beam to the size of the x-ray cassette in use. Most motorized collimator assemblies include a light-centring device. An X-ray collimator is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IZW","productCodeName":"Collimator, Automatic, Radiographic"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}