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

    LUMINOS AGILE

    K Number: K111292 · Decision Jun 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    781
    Review Days
    28

    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
    LUMINOS AGILE
    K Number
    K111292
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    May 6, 2011
    Decision Date
    June 3, 2011
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    Similar 510(k) Clearances

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

    Nexus DRF Digital X-ray Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Insight Enhanced™ DRF (EN-1002-01)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Soteria E-View

    FDA 510(k)
    FDA Class 2 ·Radiology

    Adora DRFi (04550010)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIDENT Mobile Fluoroscopy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ProxiDiagnost N90 / Precision CRF (706110, 706400)

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

    Other Clearances by Siemens Medical Solutions USA, Inc.

    K Number Device Name
    K253678 MAMMOMAT B.brilliant (11372950)
    K260844 ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
    K261315 Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family
    K254184 syngo Application Software
    K254173 ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
    K253752 ARTIS genio floor; ARTIS icono.explore floor
    K253574 SOMATOM X.cite; SOMATOM X.ceed
    K254016 MI View&GO
    K253487 ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
    K253457 ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System
    Search all 781 clearances from Siemens Medical Solutions USA, Inc. →