LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181485
    Device Name
    EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
    Manufacturer
    Philips Ultrasound, Inc.
    Date Cleared
    2018-07-27

    (51 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K172607
    Why did this record match?
    Device Name :

    EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/ Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

    Device Description

    The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). The removable transducers are connected to the system using a standard technology, multi-pin connectors.

    AI/ML Overview

    The Philips EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50, and Affiniti 70 Diagnostic Ultrasound Systems are general purpose, software-controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and display it in various modes of operation. They consist of a system console and transducers.

    The device's performance was evaluated through non-clinical testing to demonstrate substantial equivalence to a predicate device (Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, K172607). No clinical studies were required.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Safety and Performance Standards)Reported Device Performance (Compliance)
    Acoustic output display requirements of IEC 60601-2-37 Ed 2.0 and IEC 62359.System and transducers are compliant.
    FDA ultrasound guidance document: "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 9, 2008).System complies with the guidance document.
    Ispta.3 ≤ 720 MW/cm2Met (acoustic output limits are within this range).
    MI
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1