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

    MULTIX Impact

    K Number: K182517 · Decision Jan 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    32
    Review Days
    120

    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
    MULTIX Impact
    K Number
    K182517
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medi Cal Solutions, Inc.
    Date Received
    September 13, 2018
    Decision Date
    January 11, 2019
    Product Code
    KPR
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPR System, X-Ray, Stationary

    Similar 510(k) Clearances

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

    DRE Duo

    FDA 510(k)
    FDA Class 2 ·Radiology

    AeroDR TX c02

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    uDR Arria & uDR Aris

    FDA 510(k)
    FDA Class 2 ·Radiology

    uDR Aurora CX

    FDA 510(k)
    FDA Class 2 ·Radiology

    Definium Tempo Select

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

    Other Clearances by Siemens Medi Cal Solutions, Inc.

    K Number Device Name
    K193216 syngo.CT Lung CAD
    K182639 MOBILETT Elara Max
    K181279 Ysio Max
    K173639 Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
    K173408 Mammomat Revelation
    K172832 Insight BD
    K171766 Acuson SC2000 Diagnostic Ultrasound System
    K170315 Acuson SC2000 Diagnostic Ultrasound System
    K162102 MAGNETOM Avantofit, MAGNETOM Skyrafit
    K162417 Acuson Freestyle Ultrasound System
    Search all 32 clearances from Siemens Medi Cal Solutions, Inc. →