TIMS ResourcesRegulatory & Conformance Classifications & Approvals ISO 13485 ISO 13485 FDA 510(k) FDA 510(k) CE CE Health Canada Health Canada IEC/EN 60601-1-2 IEC/EN 60601-1-2 ES 60601-1 ES 60601-1 CSA 60601-1 CSA 60601-1 DICOM Conformance Statement DICOM Conformance DICOM Conformance