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

    MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit

    K Number: K153343 · Decision Apr 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    32
    Review Days
    148

    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
    MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
    K Number
    K153343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medi Cal Solutions, Inc.
    Date Received
    November 19, 2015
    Decision Date
    April 15, 2016
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

    Similar 510(k) Clearances

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

    uMR Astra

    FDA 510(k)
    FDA Class 2 ·Radiology

    APERTO Lucent MRI System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    S-scan Open (100001800)

    FDA 510(k)
    FDA Class 2 ·Radiology

    nordicAudio (1.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Embrace Neonatal MRI System

    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
    K182517 MULTIX Impact
    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
    Search all 32 clearances from Siemens Medi Cal Solutions, Inc. →