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

    HDR 1000 PLUS WELL CHAMBER, MODEL 90008

    K Number: K060532 · Decision Apr 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    10
    Review Days
    42

    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
    HDR 1000 PLUS WELL CHAMBER, MODEL 90008
    K Number
    K060532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Standard Imaging, Inc.
    Date Received
    February 28, 2006
    Decision Date
    April 11, 2006
    Product Code
    JAQ
    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
    JAQ System, Applicator, Radionuclide, Remote-Controlled

    Similar 510(k) Clearances

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

    MAASTRO Rectal Applicator Set

    FDA 510(k)
    FDA Class 2 ·Radiology

    Rectal Applicator

    FDA 510(k)
    FDA Class 2 ·Radiology

    Guided Aarhus Applicator Set

    FDA 510(k)
    FDA Class 2 ·Radiology

    CT/ MR Tandem and Ovoid Set

    FDA 510(k)
    FDA Class 2 ·Radiology

    Intracavitary/Interstitial System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Titanium Flexible Geometry FSD Applicator Set (GM11013400)

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

    Other Clearances by Standard Imaging, Inc.

    K Number Device Name
    K103193 DOSEVIEW 3D
    K082773 STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
    K042733 STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
    K040688 STANDARD IMAGING E.IMRT CALCULATOR
    K013548 STANDARD IMAGING IVB 1000 WELL CHAMBER
    K002833 MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
    K001825 STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER
    K940539 STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
    K922554 STANDARD IMAGING HDR 1000 ION CHAMBER