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Title: | MEDICAL ELECTRICAL EQUIPMENT-PART 1:GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE | |
Company: | INVIVO CORPORATION - Gainesville, FL USA | |
Product Information: | Trade Name(s): Philips, Invivo.
dStream Interface, Philips, Model Nos. dStream Interface 1.5T, 9896-032-0934x, 9896.030.1894x, 9896-032-1657x (Jabil Circuit) dStream Interface 3.0T, 9896-032-0935x, 9896.030.1901x, 9896-032-1658x (Jabil Circuit)
Tabletop Breast MRI Coil systems - Component, Model Nos. Sentinelle Breast MRI 8CH Tabletop for Siemens 1.5T, Sentinelle Breast MRI 8CH Tabletop for Siemens 3T, Sentinelle Breast MRI 4CH Tabletop for Siemens 1.5T, Sentinelle Breast MRI 8CH Tabletop for Toshiba 1.5T, Sentinelle Breast MRI 8CH Tabletop for Toshiba 3T. Also tested to IEC 60601-2-33.
UroNav, Invivo, Model Nos. 4598-013-43881, 4598-014-74781, 300005985881, 300005984991, 300009513781, 300009513911, 300005984992, 4598-014-74782 Also tested to: IEC 60601-1-6. | |
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Evaluated to the following: | A representative sample of the listed devices have been tested, investigated and found to comply with the requirements of the Standard(s) for Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (CAN/CSA C22.2 No. 60601-1) and are identified as CLASSIFIED with the cETL Listed Mark.; A representative sample of the listed devices have been tested, investigated and found to comply with the requirements of the Standard(s) for Outline of Investigation for Medical Electrical Equipment and Systems (CAN/CSA-C22.2 No. 60601-1) and are identified with the CETL Classified Mark.; A representative sample of the listed devices have been tested, investigated and found to comply with the requirements of the Standard(s) for Outline of Investigation for Medical Electrical Equipment and Systems - Medical Equipment General Requirements (CAN/CSA-C22.2 No. 60601-1) and are identified with the CETL Classified Mark. | |
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