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510(k) Data Aggregation

    K Number
    K973342
    Device Name
    DAR-3000B
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    1997-10-08

    (33 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K920720,K955395
    Why did this record match?
    Reference Devices :

    K920720, K955395

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

    · This device is intended to be used in Angiography in Hospital with the X-ray devices.. · This device is operated and used by Physicians and X-ray technologist. · The object of this device is total patient populations. As mentioned at "Intended Use" in this clearance letter, the intended use of the DAR-3000B is the same as that of predicate device IDR-1000 (K920720) and DAR-2400-15B/30B (K955395). Consequently, the indications for use of the DAR-3000B are also the same as that of the IDR-1000 (K920720) and DAR-2400-15B/30B (K955395) , and there are no additional indications.

    Device Description

    DAR-3000B Digital Subtraction Angiography System

    AI/ML Overview

    The provided documents (FDA 510(k) clearance letter dated August 8, 1997, and Indications for Use statement for the DAR-3000B Digital Subtraction Angiography System) do not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them.

    These documents are primarily concerned with the regulatory clearance of the device based on substantial equivalence to predicate devices (IDR-1000 and DAR-2400-15B/30B). They state that the intended use and indications for use of the DAR-3000B are the same as its predicate devices.

    Therefore, it is not possible to provide the requested information, including:

    1. A table of acceptance criteria and the reported device performance: The documents do not specify any performance metrics or acceptance criteria for the DAR-3000B itself, nor do they report any performance data.
    2. Sample size used for the test set and the data provenance: This information is not present.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
    4. Adjudication method for the test set: Not mentioned.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned. This type of study is more common for AI-based devices; this device is a Digital Subtraction Angiography System, which is hardware.
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a hardware system.
    7. The type of ground truth used: Not mentioned.
    8. The sample size for the training set: Not applicable, as this is a medical device, not an AI algorithm requiring a training set in the machine learning sense.
    9. How the ground truth for the training set was established: Not applicable.

    The clearance is based on the device being "substantially equivalent" to previously cleared devices, implying that its performance is considered comparable without requiring a new, independent clinical study demonstrating specific performance metrics against defined acceptance criteria.

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