BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Philips Medical Systems (Cleveland), Inc.

    Reg #: 3018004899 · FEI: 3018004899 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Philips Medical Systems (Cleveland), Inc.
    Registration Number
    3018004899
    FEI Number
    3018004899
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3630 SW 47th Avenue
    City
    Gainesville
    State
    FL
    ZIP
    32608
    Country
    US

    Regulatory Submissions

    510(k) Number
    K926008

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE
    System, Planning, Radiation Therapy Treatment MUJ
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Pinnacle3 Pinnacle 3 Radiation Therapy Planning System Pinnacle3 Rad Therapy Plan System Pinnacle3 Radiation Therapy Planning System Pinnacle3 Radiation Therapy Treatment Planning System Pinnacle Radiation Therapy Planning System version 16.2 Pinnacle3 Apex P3IMRT Pinnacle3 Radiation Therapy Planning System SmartArc Module

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device