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| Title: | MEDICAL ELECTRICAL EQUIPMENT: BASIC SAFETY & ESSENTIAL PERFORMANCE | |
| Company: | INVIVO CORPORATION - Gainesville, FL USA | |
| Product Information: | Trade Name(s): Invivo.
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) Medical Electrical Equipment, Part 1: General Requirements for Basic Safety & Essential Performance (AAMI-ES60601-1) and are identified as CLASSIFIED with the ETL Listed Mark. | |
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