BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Philips DS North America LLC

    Reg #: 3023385454 · FEI: 3023385454 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    70
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    Philips DS North America LLC
    Registration Number
    3023385454
    FEI Number
    3023385454
    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
    K182561

    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
    System, Image Processing, Radiological LLZ
    Radiological Image Processing Software For Ablation Therapy Planning And Evaluation QTZ
    Guide, Needle, Surgical GDF
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    UroNav 3 784027, DynaCAD UroNav UroNav 4 INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly GEMS and Clamp Stand INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly PHC and Clamp Stand INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, HITACHI INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly Skyra, SHC Needle Sleeve 16G Sentinelle, Biopsy Grid 459801508642 Breast Grid (User-Sterilized) 989603209144 Lateral Grid dS Breast 16CH I/T Breast Grid (User-Sterilized) 989603203484 MRI Needle Block 18G Pillar Immobilization Plate Pillar Immobilization Plate LBS M-L Lateral Grid, Lower dS Breast 16CH I/T Lateral Grid, Upper dS Breast 16CH I/T Needle Sleeve 18G 989603203464 MRI Needle Block 12G 989603203584 Mammotome Immobilization Plate 989603209104 Pillar Immobilization Plate Fiducial Marker Grid Block Assembly Needle Sleeve 12G Fiducial Holder Needle Sleeve 14G 989603203594 OBC Grid Immobilization Plate 989603214204 Biospy Grid, Sterilized Pillar Immobilization Plate BBC Needle Block, 16G 989603209064 Grid Immobilization Plate LBS MRI Needle Block 8G Needle Block, 12G Pillar Immobilization Plate LBS C-C Fiducial Marker Sleeve Assembly Needle Block Holder MRI Needle Sleeve 12G Pillar Immobilization Plate BBC Grid Immobilization Plate LBS C-C Grid Plate, Enhanced Access Lateral Grid Immobilization Plate LBS M-L Medial Grid dS Breast 16CH 1/T 459801507722 Biospy Grid, Sterilized 989603203474MRI Needle Block 14G Grid Plate, Enhanced Access Medial 989603203574 Pillar Immobilization Plate OBC INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly SMS and Clamp Stand 989603203524 Grid Immobilization Plate Needle Hub Assembly 989603204304 MRI Needle Block 16G INVIVO (FLORIDA, USA): DynaTRIM Complete, HITACHI DynaTRIM Grid Immobilization Plate OBC INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, GEMS Biopsy Grid Needle Block, 14G INVIVO (FLORIDA, USA): DynaTRIM Complete, Skyra Baseplate assembly SHC and Clamp Stand Grid Immobilization Plate BBC INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, SMS Needle Block, 18G Lateral Grid dS Breast 16CH 1/T INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, PHC INVIVO (FLORIDA, USA): DynaTRIM Clamp stand assembly INVIVO (FLORIDA, USA): DynaTRIM Complete, GEMS DynaTRIM DynaCAD DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) UroNav Fusion Biopsy System ESys FMRI UPGRADE, ESys PATIENT ENTERTAINMENT SYSTEM ESys fMRI SensaVue fMRI SensaVue HD (Entertainment)

    Establishment Types

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