510(k) K252653

ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable by Acist Medical Systems, Inc. — Product Code DXT

K252653 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable". The FDA issued a decision of Substantially Equivalent on May 13, 2026. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Acist Medical Systems, Inc. has at least 10 other 510(k) clearances on record.