Software

Sonora Medical Systems' Acoustic Measurement System (AMS) Software is based on 20 years of experience in measuring and reporting medical ultrasound data to government regulatory bodies. Dr. Mark Schafer submitted his first Food and Drug Administration 510(k) acoustic output report in 1984 as a consultant to Interspec, Inc in collaboration with Dr. Peter Lewin. These early measurements were done before the 1985 FDA Guidance document that provided a uniform reporting format and measurement approach. In fact, several aspects of the 1985 Guidance document were based on parts of Dr. Schafer's original acoustic output reports

Dr. Schafer and the staff at Sonora Medical Systems have been continuously involved in regulatory ultrasound measurements since the mid 1980s. AMS Software has been described in publications since 1988 and has evolved by design to meet the increasingly sophisticated demands of the medical ultrasound industry. Over the years, specialized versions of AMS Software have been developed for IEC 1157 requirements (now obsolete but still available) and lithotripsy measurements. AMS software now meets the needs of IEC 60601-2-37 (NEMA UD-3, or FDA Track III), otherwise known as the Output Display Standard.
 

 
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