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

    VIRTUOSO SYSTEM FOR IHC ER (SPI)

    K Number: K130515 · Decision Nov 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    14
    Applicant Total
    48
    Review Days
    268

    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
    VIRTUOSO SYSTEM FOR IHC ER (SPI)
    K Number
    K130515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ventana Medical Systems, Inc.
    Date Received
    February 27, 2013
    Decision Date
    November 22, 2013
    Product Code
    NQN
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

    Similar 510(k) Clearances

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

    GENASIS HIPATH IHC FAMILY

    FDA 510(k)
    FDA Class 2 ·Hematology

    VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER

    FDA 510(k)
    FDA Class 2 ·Hematology

    VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

    FDA 510(k)
    FDA Class 2 ·Hematology

    VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER

    FDA 510(k)
    FDA Class 2 ·Hematology

    VIRTUOSO SYSTEM FOR IHC P53 (DO-7)

    FDA 510(k)
    FDA Class 2 ·Hematology

    VIRTUOSO SYSTEM FOR IHC PR (IE2)

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

    Other Clearances by Ventana Medical Systems, Inc.

    K Number Device Name
    K242783 Roche Digital Pathology Dx
    DEN240025 VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
    K232879 Roche Digital Pathology Dx (VENTANA DP 200)
    K212176 CINtec Histology
    K172471 VENTANA CD30 (Ber-H2) RxDx Assay
    DEN160019 CINtec Histology (50 tests), CINtec Histology (250 tests)
    K142965 Virtuoso System for IHC PR (1E2) using iScan HT
    K140465 VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
    K121516 VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
    K122143 VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
    Search all 48 clearances from Ventana Medical Systems, Inc. →