BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    PERIMETER MEDICAL IMAGING AI, INC.

    Reg #: 3013276158 · FEI: 3013276158 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    PERIMETER MEDICAL IMAGING AI, INC.
    Registration Number
    3013276158
    FEI Number
    3013276158
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    555 Richmond St W, Suite 511
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K203578
    PMA Number
    P250008

    Owner / Operator

    Firm Name
    Perimeter Medical Imaging AI
    Operator Number
    10052944
    Address
    555 Richmond St W, Suite 511
    City
    Toronto
    State
    Ontario
    Postal Code
    M5V 3B1
    Country
    CA
    Correspondent
    Emily Campbell

    US Agent

    Business Name
    Perimeter Medical Imaging AI
    Contact Name
    Sara Brien
    Address
    8585 N Stemmons Fwy, Suite 106N
    City
    Dallas
    State
    TX
    ZIP
    75247
    Country
    US
    Email
    [email protected]
    Phone
    650 7889246

    Products

    Device Name Product Code
    System, Imaging, Optical Coherence Tomography (Oct) NQQ
    Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer SHH

    Proprietary Names

    Perimeter S-Series OCT Perimeter OTIS™ 2.1 Optical Coherence Tomography System THiA B-Series OCT System Claire™ OCT System

    Establishment Types

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