BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Martinez Prostate Template Set

    K Number: K142439 · Decision Mar 10, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    11
    Review Days
    193

    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
    Martinez Prostate Template Set
    K Number
    K142439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nucletron B.V.
    Date Received
    August 29, 2014
    Decision Date
    March 10, 2015
    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 Nucletron B.V.

    K Number Device Name
    K251037 Rectal Applicator
    K213942 Esteya
    K201272 Geneva
    K161688 Advanced Gynecological Applicator
    K151272 Henschke Titanium Applicator Set
    K140803 LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
    K132816 ONCENTRA BRACHY
    K132889 FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
    K132874 LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM
    K132092 ESTEYA
    Search all 11 clearances from Nucletron B.V. →