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510(k) Data Aggregation

    K Number
    K200585

    Validate with FDA (Live)

    Device Name
    Acuson SC2000 Diagnostic Ultrasound System
    Manufacturer
    Siemens Medical Solutions, USA, Inc.
    Date Cleared
    2020-04-22

    (47 days)

    Product Code
    IYN,ITX,IYO,OBJ
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K181098
    Predicate For
    K201062,K202683
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

    The typical examinations performed using the SC2000 Ultrasound System are:

    Cardiac Imaging Applications and Analysis
    Vascular Imaging Applications and Analysis
    Superficial Imaging Applications
    Intraoperative Imaging Applications
    Transcranial Imaging Applications

    Device Description

    The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display. The transducer and catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a).

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification for the ACUSON SC2000 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

    Therefore, the document does not contain the information requested in your prompt regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or its data provenance.
    3. Number of experts used to establish ground truth or their qualifications.
    4. Adjudication method for the test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
    6. Standalone performance results.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.

    The document explicitly states in "Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence" that: "Since the ACUSON SC2000 VC10A (v6.0) Diagnostic Ultrasound System uses the identical technology and principles of use as the existing predicate devices SC2000. VB21A (v5.1) K181098, clinical studies were not required to support substantial equivalence."

    The non-clinical tests mentioned in Part 7 are related to device safety standards (acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety), not performance against clinical acceptance criteria.

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