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

    PHANTOM

    K Number: K941363 · Decision Jul 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    223
    Applicant Total
    9
    Review Days
    121

    Basic Information

    Device Name
    PHANTOM
    K Number
    K941363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DYNARAD CORP.
    Date Received
    March 21, 1994
    Decision Date
    July 20, 1994
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

    Similar 510(k) Clearances

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

    Europa (Alternative: AiRTouch) portable X-ray system

    FDA 510(k)
    FDA Class 2 ·Radiology

    !M1

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRA 1040

    FDA 510(k)
    FDA Class 2 ·Radiology

    TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRX-Revolution Mobile X-ray System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Digital Radiography System (ManntiX B, ManntiX K)

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

    Other Clearances by DYNARAD CORP.

    K Number Device Name
    K000052 X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
    K981267 FACTS MONOBLOCK
    K973833 CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL
    K932356 NOVA XM2
    K932353 HF-110A
    K932355 9150A, 1100F
    K932354 9170, 1170
    K931725 ALPHA II