BEUDAMED
    Product Code: IYT FDA class 2 21 CFR 892.1390

    System, Rebreathing, Radionuclide

    Radiology

    A radionuclide rebreathing system is used in nuclear medicine to deliver radioactive gases or aerosols to patients for ventilation lung imaging studies, enabling assessment of pulmonary function and airflow distribution. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is IYT, regulated under 21 CFR 892.1390, within the Radiology medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    48
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    18
    Years Active
    42

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    Basic Information

    Product Code
    IYT
    Device Class
    FDA class 2
    Regulation Number
    892.1390
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 48 510(k) clearances via K numbers.

    K Number Device Name
    K200916 Patient Administration Set
    K953513 XENON CIRCUIT
    K952223 XENON GAS BREATHING CIRCUIT
    K914747 XENON CIRCUIT
    K913416 TETLEY PATIENT ADMINISTRATION SET
    K912626 BOLUS XENON CIRCUIT
    K904684 AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION
    K903805 AMICI XENON ADMINISTRATION SET
    K903694 AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE
    K896885 DISPOSABLE RESPIRTORY KIT (MP-200)
    K896125 MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M
    K896476 DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD
    K896475 DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD
    K896124 MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133
    K881812 AERO-MIST NEBULIZER
    K871868 VENTI-SCAN II
    K872920 AMICI KRYPTON ADMINISTRATION SYSTEM*
    K865107 AERO-VENT AEROSOL UNIT
    K865084 AMICI XENON REBREATHING SYSTEM*
    K863996 MODEL XE-103 XENON/MASTER II
    K863778 VENTICIS II
    K862795 MP-070-M RADIOAEROSOL KIT
    K862794 MP-070 RADIOAEROSOL KIT
    K862793 MP-066-M RADIOAEROSOL KIT
    K862792 MP-066 RADIOAEROSOL KIT
    K862791 MP-30XM-IE FACE MASK AND FILTER KIT
    K853579 MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133
    K853576 MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M
    K853570 MEDIPART DRIERITE MP-1002
    K851201 MEDIPART LUND AEROSOL KIT MP-1024A-M
    K851200 MEDIPART LUNG AEROSOL KIT MP-1024A
    K851199 MEDIPART LUNG AEROSOL KIT MP-1012A-M
    K851198 MEDIPART LUNG AEROSOL KIT MP-1012A
    K850837 MEDIPART FACE MASK & FILTER MP-30XM-I
    K850836 MEDIPART FACE MASK MP-XM-I
    K853056 RESPIR GARD-II FACE MASK CORRUGATED TUBING
    K852693 XEN-REX I
    K850367 MEDIPART XENON BREATHING KIT MP-02XM-I
    K850366 MEDIPART XENON BREATHING KIT MP-OIXM-I
    K843640 XENON XE 127/XE 133 GAS DISPENSER
    K844496 MEDIPART XENON BREATHING KIT MP-01XM
    K844495 MEDIPART XENON BREATHING KIT MP-02XM
    K820571 XENAMATIC SERIES OF XENON REBREATH DEV
    K820143 XENON DELIVERY SYSTEM
    K811118 KRYPTON MASKS & TUBING
    K810819 MEDI/NUCLEAR #XE-102 XENON/MASTER
    K781933 DISPENSOR, XENON GAS
    K781107 DISPENSER, GAS XENON

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.