Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250039

    Validate with FDA (Live)

    Device Name
    HPACS
    Manufacturer
    Date Cleared
    2025-10-03

    (268 days)

    Product Code
    Regulation Number
    892.2050
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HPACS is a web-based software solution intended for storing, retrieving, transmitting, viewing, and processing medical images for non-diagnostic purposes. It operates in conjunction with a PACS server to enable access to imaging data.

    HPACS supports the display and comparison of images from CR, CT, DX, MR, US, XA, and SC modalities that are compliant with the DICOM standard.

    The system is designed for use by radiologists, technologists, and clinicians for reference and review purposes only. It is not intended for primary diagnostic interpretation.

    HPACS supports operation on Windows 10 or higher and macOS 12 or higher platforms, exclusively via Google Chrome browser. Compatibility with other browsers or operating systems is not claimed.

    HPACS is not intended for diagnostic image reading and should be used under standard indoor lighting conditions for optimal viewing; use in direct sunlight or high-glare environments is not recommended, and mobile or tablet devices are not supported. HPACS is not supported on any OS that is no longer officially supported by its manufacturer (e.g., Windows 7).

    Device Description

    HPACS is a software system that allows healthcare professionals to access and manipulate medical images in real time using any web browser without device/location restrictions, without installing client software. The PACS application program runs on the AWS Cloud server. It stores, searches, and retrieves medical images and meta information using an initialization database based on secure communication, logging, DICOM tags stored in the DB, and file storage information stored in the AWS Cloud. AWS Cloud provides storage, query, and retrieval functions only to authorized users, and blocks unauthorized access. It also provides a web browser-based PACS/Web Viewer UI that can interact with the PACS application program to store and retrieve medical images and meta information.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1