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Key Certifications

 

Optoacoustics' IMROC communications system, OptoACTIVE noise-cancelling headset and FOMRI-III noise-cancelling microphone are US FDA 510(k) cleared.

 

SIEMENS AG
Erlangen

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.

View Certificate

 

ISO 9001 (2008)

Optoacoustics products are manufactured under control of a Quality Management System which meets the requirements of ISO 9001:2008 as certified by IQC. 2008
 

ISO 13485 (2003)

Optoacoustics products are manufactured under control of a Quality Management System which meets the requirements of ISO 13485:2003 as certified by IQC. 2003
 

IEC 60601-1

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.  
 

EN 60601-1

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.  
 

IEC 60601-1-2

Optoacoustics' IMROC system meets the requirements of IEC 60601-1-2 (2001) EMC Testing as certified by ITL.  
 

CISPR 11

Optoacoustics' IMROC system meets the requirements of CISPR 11 (2004), Class A and Amendment #A2 (2006) as certified by ITL.  
 

IEC 61000

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.  
 

ISO 3745 (2003)

Optoacoustics' anechoic chamber performance has been validated in accordance with ISO 3745:2003.