BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Source-Ray, Inc.

    Reg #: 3004606964 · FEI: 3004606964 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    Source-Ray, Inc.
    Registration Number
    3004606964
    FEI Number
    3004606964
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    50 Fleetwood Ct
    City
    Ronkonkoma
    State
    NY
    ZIP
    11779
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052001

    Owner / Operator

    Firm Name
    Source-Ray, Inc.
    Operator Number
    10021863
    Address
    50 Fleetwood Court
    City
    Ronkonkoma
    State
    NY
    Postal Code
    11779
    Country
    US
    Correspondent
    Theophilos Theophilou

    Products

    Device Name Product Code
    System, X-Ray, Mobile IZL
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR

    Proprietary Names

    SR-115 XRS-140-15K-P XRS-140-7.5K-P XRS-125-7K-P PowerMax 1260 SR-130 SB-60-333 Optional Remote Control RC-115 PXS-710D UC-5000

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)