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The MITS DICOM Gateway and Image Manager is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources ( i.e. ultrasound system, R/F units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
To support the diagnostic interpretation of mammography studies the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.

MITS DICOM Gateway and Image Manager is a suite of applications designed and produced by MITSMED Medical Instrument Technology CO., Ltd. It is a client-server based software system manages archiving, retrieving and displaying medical images. The DICOM converter application is MITS DICOM Gateway. The server side is MITS Image Manager SERVER. And the client side is MITS Image Manager CLIENT.

The provided text is a 510(k) summary for the MITS DICOM Gateway and Image Manager. It describes the device's administrative information, intended use, technological characteristics, and claim of substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

The document primarily focuses on:

• Administrative Information: Manufacturer, contact, date prepared, device name, classification, regulation number, product code.
• Device Description: A client-server based software system for archiving, retrieving, and displaying medical images. Functions include DICOM conversion, server management, and client display.
• Intended Use: Capturing, receiving, storing, communicating, processing, and displaying 2D and 3D medical images from various sources. It specifies use by trained medical professionals and requirements for mammography interpretation (non-compressed DICOM, FDA-approved 5Mpixel monitor).
• Technological Characteristics: Software server application, no patient contact, no control over life-sustaining devices, human intervention for interpretation.
• Substantial Equivalence: Claims equivalence to CSIST DICOM Gateway and Image Manager (K012327) based on similar working principles and technologies, with differences attributed to feature design not affecting safety or effectiveness. It references software validation and risk analysis results.
• FDA Determination: A letter from the FDA stating substantial equivalence and outlining regulatory compliance requirements.

To answer your questions about acceptance criteria and performance studies, such information would typically be found in a separate section of a 510(k) submission, often under "Performance Data" or "Clinical Data," which is absent here.

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