BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    BRAINLAB STEROTATIC HEADRING

    K Number: K952390 · Decision Feb 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    246
    Registration Numbers
    246
    Same Product Code
    417
    Applicant Total
    5
    Review Days
    256

    Basic Information

    Device Name
    BRAINLAB STEROTATIC HEADRING
    K Number
    K952390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BRAINLAB MED. COMPUTERSYSTEME GMBH
    Date Received
    May 22, 1995
    Decision Date
    February 2, 1996
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

    Similar 510(k) Clearances

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

    EZ-FIDUCIALS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stereotaxic Guiding Surgical Devices, NaoTrac S

    FDA 510(k)
    FDA Class 2 ·Neurology

    Navient Image Guide Navigation System (955-NC-NC), Cranial

    FDA 510(k)
    FDA Class 2 ·Neurology

    Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT

    FDA 510(k)
    FDA Class 2 ·Neurology

    ClearPoint System (Software Version 3.0)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Geniant Cranial (Navigated Neurosurgical Positioning Robot)

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

    Other Clearances by BRAINLAB MED. COMPUTERSYSTEME GMBH

    K Number Device Name
    K970586 BRAINLAB MICRO MULTI-LEAF COLLIMATOR
    K954861 BRAINLAB CT/X-RAY LOCALIZER
    K945903 BRAINLAB MASK SYSTEM
    K934657 BRAINLAB LINAC HARDWARE