BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ISCHEMAVIEW, INC.

    Reg #: 3011205675 · FEI: 3014269683 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    ISCHEMAVIEW, INC.
    Registration Number
    3011205675
    FEI Number
    3014269683
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1120 Washington Ave, Ste 200, #108
    City
    Golden
    State
    CO
    ZIP
    80401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193087

    Owner / Operator

    Firm Name
    iSchemaView, Inc.
    Operator Number
    10047732
    Address
    1120 Washington Ave, Suite 200, Rm 108
    City
    Golden
    State
    CO
    Postal Code
    80401
    Country
    US
    Correspondent
    James R Rosa

    Products

    Device Name Product Code
    Radiological Computer-Assisted Triage And Notification Software QAS
    Software For Visualization Of Vascular Anatomy And Intravascular Devices PZO
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ
    Radiological Computer-Assisted Prioritization Software For Lesions QFM
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK

    Proprietary Names

    Rapid ICH SurgicalPreview Rapid MLS Rapid LVO Rapid Neuro 3D Lumina 3D by RapidAI Rapid N3D Lumina 3D Lumina 3D by iSchemaView iSchemaView Lumina 3D Rapid RVLV Rapid Rapid Aortic Measurement Rapid C-Arm CTP Rapid AngioFlow Rapid CTA 360 Rapid LMVO Rapid VO+ Rapid NCCT Stroke Rapid ANRT Rapid ASPECTS Rapid SDH Rapid OH RAPID Rapid PETN Rapid DelteFuse

    Establishment Types

    Manufacture Medical Device