510(k) K172216

ACIST RXi Mini System by Acist Medical Systems, Inc. — Product Code DRQ

K172216 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ACIST RXi Mini System". The FDA issued a decision of Substantially Equivalent on August 18, 2017. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Acist Medical Systems, Inc. has at least 10 other 510(k) clearances on record.