BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ACIST RXi Mini System

    K Number: K172216 · Decision Aug 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    26
    Applicant Total
    16
    Review Days
    25

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ACIST RXi Mini System
    K Number
    K172216
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2060
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acist Medical Systems, Inc.
    Date Received
    July 24, 2017
    Decision Date
    August 18, 2017
    Product Code
    DRQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRQ Amplifier And Signal Conditioner, Transducer Signal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DRQ), ordered by most recent decision date.

    CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Acist Medical Systems, Inc.

    K Number Device Name
    K252653 ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
    K252638 VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)
    K233904 ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
    K203004 ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
    K193183 ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
    K190473 ACIST RXi System and Navvus II Catheter
    K191060 ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
    K191175 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
    K171646 ACISTCVi® Contrast Delivery System
    K173063 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
    Search all 16 clearances from Acist Medical Systems, Inc. →