Search Results
Found 1 results
510(k) Data Aggregation
K Number
K200132Device Name
Ashvins
Manufacturer
MedicalCommunications GmbH
Date Cleared
2020-02-18
(28 days)
Product Code
LLZ, CLA, NFJ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MedicalCommunications GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.
Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.
For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.
Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.
Device Description
Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammoqraphic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.
Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.
Ashvins does not utilize artificial intelligence or computer-aided diagnosis to identify abnormalities in medical images or to assist in diagnosis.
For primary image diagnosis in Mammography only uncompressed images and only preprocessed DICOM *For Presentation" images must be used. Existing regulatory or legal require-ments regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.
Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiolo-gists, ophthalmologists, nurses, medical technicians, and assistants.
Ashvins integrates systems including, but not limited to, devices and information systems for medical practices and hospitals (such as radiology and/or ophthalmology information systems, etc.) in accord-ance with international standards. Ashvins also provides manufacturer-specific interfaces for other sys-tems/devices.
Ashvins offers the possibility of capturing and digitizing documents such as PDFs, single images, image sequences and film sequences, as well as converting and archiving them in DICOM format. As such, Ash-vins serves as a manufacturer-independent image management system and archive, a so-called "Vendor Neutral Archive."
Ashvins also provides functions for the collection, processing, and transfer of medical and administrative data in hospitals or medical practices, including billing functions.
Ashvins allows the visualization and statistical evaluation of meta data provided by the devices.
Ashvins is used at a physician's workplace to assist the physician with diagnosis and treatment planning, but the product itself does not generate an automated diagnosis, findings, or a treatment plan. The final decision regarding the diagnosis always remains with the physician or the medical staff within their own decision-making area.
Ashvins is offered in different variants with different ranges of functions for different application areas depending on the configuration (for further information see document "General Description of Product Vari-ants").
Ask a Question
Page 1 of 1