MDR Class I Medical
Device Notification (2022)
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Optoacoustics' OptoACTIVE and IMROC systems are certified by Obelis Europe as MDR Class I Medical Devices, effective February 25, 2022. |
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SIEMENS AG
Erlangen
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Optoacoustics' IMROC, FOMRI-III and OptoACTIVE systems are compatible and safe for use in Siemens AG MRI systems worldwide, as specified in their certificate dated April 15, 2011. |
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ISO 9001 (2008)
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Optoacoustics products are manufactured under control of a Quality Management System which meets the requirements of ISO 9001:2008 as certified by IQC. |
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ISO 13485 (2003)
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Optoacoustics products are manufactured under control of a Quality Management System which meets the requirements of ISO 13485:2003 as certified by IQC. |
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IEC 60601-1
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Optoacoustics' IMROC, FOMRI-III and OptoACTIVE systems meet the requirements of IEC 60601-1 (1988) Medical electrical equipment - Part 1 General requirements for Safety, 2nd Edition, including Amendments #1 (1991) and #2 (1995) as certified by ITL. |
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EN 60601-1
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Optoacoustics' IMROC, FOMRI-III and OptoACTIVE systems meet the requirements of EN 60601-1 (1990) Medical electrical equipment - Part 1 General requirements for Safety, including Amendments #1 (1993), #2 (1995) and #13 (1996) as certified by ITL. |
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IEC 60601-1-2
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Optoacoustics' IMROC system meets the requirements of IEC 60601-1-2 (2001) EMC Testing as certified by ITL. |
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CISPR 11
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Optoacoustics' IMROC system meets the requirements of CISPR 11 (2004), Class A and Amendment #A2 (2006) as certified by ITL. |
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IEC 61000
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Optoacoustics' IMROC system meets the requirements of IEC 61000-3-2 Class A (2000), IEC 61000-3-3 (1995) and Amendments #A1 (2001) and #A2 (2005), IEC 61000-4-2 (2001), IEC 61000-4-3 (2002), IEC 61000-4-4 (2004), IEC 61000-4-5 (2005), IEC 61000-4-6 (2006), IEC 61000-4-8 (2001), and IEC 61000-4-11 (2004) as certified by ITL. |
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ISO 3745 (2003)
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Optoacoustics' anechoic chamber performance has been validated in accordance with ISO 3745:2003. |
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