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

    EUP-OL334 LAPARASCOPICPROBE

    K Number: K981434 · Decision Jul 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    32
    Review Days
    97

    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
    EUP-OL334 LAPARASCOPICPROBE
    K Number
    K981434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Medical Corp. of America
    Date Received
    April 21, 1998
    Decision Date
    July 27, 1998
    Product Code
    ITX
    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
    ITX Transducer, Ultrasonic, Diagnostic

    Similar 510(k) Clearances

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

    ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mendaera Guidance System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Accuro® 3S Needle Guide Kit

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ultrasound Transducer Cover

    FDA 510(k)
    FDA Class 2 ·Radiology

    UltraDrape UGPIV Barrier and Securement (34-15)

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

    Other Clearances by Hitachi Medical Corp. of America

    K Number Device Name
    K994026 EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
    K991535 CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
    K991318 CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
    K991129 HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
    K954220 EUB-8000
    K962308 EUB-905
    K954143 HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
    K954129 SPECTRADIGITAL SERIES V250DSP
    K945400 HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100
    K945795 EUB-555A+
    Search all 32 clearances from Hitachi Medical Corp. of America →