BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    SPECTURN, MODEL TTK-128

    K Number: K923180 · Decision Jul 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    1
    Review Days
    391

    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
    SPECTURN, MODEL TTK-128
    K Number
    K923180
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Harpell Assoc., Inc.
    Date Received
    June 30, 1992
    Decision Date
    July 26, 1993
    Product Code
    IYX
    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
    IYX Camera, Scintillation (Gamma)

    Similar 510(k) Clearances

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

    QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)

    FDA 510(k)
    FDA Class 1 ·Radiology

    3D-RD-S

    FDA 510(k)
    FDA Class 1 ·Radiology

    OLINDA EXM

    FDA 510(k)
    FDA Class 1 ·Radiology

    Discovery NM 750b Bopsy

    FDA 510(k)
    FDA Class 1 ·Radiology

    Sentinella 102, Sentinella 102 Horus

    FDA 510(k)
    FDA Class 1 ·Radiology

    Sentinella 102; Sentinella 102 Horus

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all