BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    EXTRON 5; EXTRON 7

    K Number: K230871 · Decision Aug 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    25
    Review Days
    140

    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
    EXTRON 5; EXTRON 7
    K Number
    K230871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DRTECH Corporation
    Date Received
    March 30, 2023
    Decision Date
    August 17, 2023
    Product Code
    OWB
    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
    OWB Interventional Fluoroscopic X-Ray System

    Similar 510(k) Clearances

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

    C-beam

    FDA 510(k)
    FDA Class 2 ·Radiology

    Intelligent NR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTIS genio floor; ARTIS icono.explore floor

    FDA 510(k)
    FDA Class 2 ·Radiology

    BELLIGER ACE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Trinias

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

    Other Clearances by DRTECH Corporation

    K Number Device Name
    K250010 EXTRON 3; EXTRON 5; EXTRON 7
    K242770 EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
    K243443 EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
    K242591 XERO-alpha
    K242847 EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);
    K240243 EConsole2
    K233530 EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)
    K232082 EXPD 4343S
    K232753 EXPD 4343D; EXPD 3643D
    K231225 EConsole1
    Search all 25 clearances from DRTECH Corporation →