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510(k) Data Aggregation
K Number
K173420Device Name
Radiomics App v1.0
Manufacturer
Microsoft Corp.
Date Cleared
2017-12-27
(56 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Microsoft Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Microsoft Radiomics App v1.0 is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal organ and tumor contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. Radiomics App assists in the following scenarios:
· Load, save and display of medical images and contours for treatment evaluation and treatment planning.
· Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy, and archiving contours for patient followup.
· Localization and definition of both solid tumors and healthy anatomical structures.
- · Fusion display of compatible images for treatment planning.
· Three-dimensional rendering of medical images and the segmented contours.
Images reviewed using the Radiomics App software should not be used for primary image interpretations. Radiomics App is not for use with digital mammography.
Device Description
Microsoft Radiomics App v1.0 is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and medical physicists for radiation treatment planning.
Radiomics App stems from more than eight years of research in computerized medical image analysis, computer vision and machine learning. It applies well tested, state-of-the-art algorithms for the assisted delineation of anatomical structures of interest in three-dimensional, clinical radiological scans.
Radiomics App works on computed tomography (CT) and magnetic resonance (MR) scans, and is designed to contour/delineate both healthy anatomical structures as well as lesions such as solid tumors.
Radiomics App integrates into the clinical data network of radiation therapy treatment centers, receiving data from imaging devices such as CT and MR scanners. The purpose of the tool is to assist the expert user in producing segmentations (three-dimensional contours) of anatomical structures, for both solid tumors and healthy tissue structures. The following segmentation tools are provided:
- Assisted Contouring. This module allows for the manual, user-guided segmentation of . structures of interest in both CT and MR images.
- . Machine-learning based contouring. This module uses machine learning algorithms (ML) to provide an initial segmentation of certain structures of interest automatically. The user has the option to accept this initial segmentation or edit and refine it.
- . Contour refinement. This module allows the user to edit and improve segmentations created by either the machine learning or the assisted contouring algorithms.
These segmentations are then exported back into the clinical data network, and subsequently utilized in a radiotherapy treatment planning system to generate a treatment plan for a patient.
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K Number
K120734Device Name
MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE
Manufacturer
MICROSOFT CORP.
Date Cleared
2012-08-02
(146 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MICROSOFT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microsoft® Amalga™ UIS Image Processing Module (IPM) is used in conjunction with Microsoft® Amalga™ UIS and Microsoft® Amalga™ UIS Medical Imaging Module to receive medical images from acquisition devices and imaging systems adhering to DICOM protocol. Medical images received from volumetric or planar imaging modalities are processed to derive certain information. The information thus derived is transmitted using the DICOM or HTTP protocol to other devices supporting these standard protocols.
The IPM enables physicians and other healthcare providers to rapidly navigate across images by selecting tagged organs and review them through multi-planar reconstruction (MPR). IPM is not intended to be used for primary diagnosis.
This device is not intended to be used for mammography.
Device Description
The Microsoft® Amalga™ UIS Image Processing Module (IPM) is used in conjunction with Microsoft® Amalga™ UIS and Microsoft® Amalga™ UIS Medical Imaging Module (MIM). These two software products (Amalga™ UIS and Amalga™ MIM) are Class 1 devices that perform consolidation of disparate health information (Amalga™ UIS) and medical image communication (Amalga™ MIM). Amalga™ IPM enables healthcare providers to rapidly navigate across images by selecting tagged organs and to review these images using multi-planar reconstruction (MPR).
Amalga™ IPM delivers a basic MPR rendering platform that constructs a three-dimensional view from a set of CT, MR, or PET images. Amalga™ IPM also enables organ label based navigation through DICOM CT scans both in 2D image display and MPR viewing mode.
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