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

    ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER

    K Number: K021124 · Decision Jul 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    8
    Review Days
    85

    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
    ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
    K Number
    K021124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wfr/Aquaplast Corp.
    Date Received
    April 8, 2002
    Decision Date
    July 2, 2002
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

    Similar 510(k) Clearances

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

    ThinkQA 3

    FDA 510(k)
    FDA Class 2 ·Radiology

    LUNA 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    AerFrame Patient Immobilization System (AFPIS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERIQA RT EPID 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ClearCheck (RADCC V2.7)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AlignRT Plus (8.0)

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

    Other Clearances by Wfr/Aquaplast Corp.

    K Number Device Name
    K120916 QFIX RADIOTHERAPY CHAIR
    K060671 KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
    K032156 ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT
    K973370 AQUAPLAST PALATAL STENT
    K943871 AQUAPLAST TIE DOWN DRESSING
    K942158 AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
    K935067 AQUAPLAST