Regulatory and Quality
Interson products are designed and manufactured in the U.S.A. and have FDA 510(k) clearance, a CE mark by BSI Group, Japan PAL NINSHO approval, and a medical device license from Health Canada.
Interson’s USB probe system is compliant to:
ANSI / AAMI ES60601-1:2005+A2 (R2012)
CAN / CSA-C22.2 No. 60601-1-08
CAN / CSA-C22.2 No. 60601-2-37-08
IEC 60601-2-37:2007

FDA K070907, Listing D025894 for ITX and IYO, Operator 9000675, Registration 2939830
BSI Group Certs FM 596532 and CE 596785
Health Canada Company ID 130112 Lic # 81976
Japan NINSHO 223ADBZX00046000
California FDB 63642
GMDN – 11389, 40761, 40762
UMDNS – 11389, 15976, 15657

SeeMore Imaging Canada MDEL license #4686

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