Search Results
Found 2 results
510(k) Data Aggregation
K Number
K193300Device Name
AIMI-Triage CXR PTX
Manufacturer
RADLogics, Inc.
Date Cleared
2020-04-08
(133 days)
Product Code
QFM, OFM
Regulation Number
892.2080Why did this record match?
Applicant Name (Manufacturer) :
RADLogics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes caselevel output available to a PACS/workstation for worklist prioritization or triage. Identification of suspected cases of moderate to large sized pneumothorax is not for diagnostic use beyond notification.
The AIMI-Triage CXR PTX Application is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review, and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. Notified radiologists are responsible for engaging in appropriate patient evaluation as per local hospital procedure before making care-related decisions or requests. The device does not replace review and diagnosis of the X-rays by radiologists. The device is not intended to be used with plain film X-rays.
Device Description
The AIMI-Triage CXR PTX provides a chest X-ray prioritization service for use by radiologists to identify features suggestive of moderate to large sized pneumothorax. The artificial intelligence algorithm, trained via pattern recognition, processes each chest X-ray and flags those that appear to contain a moderate to large sized pneumothorax for urgent radiologist review. X-rays without an identified anomaly are placed in the worklist for routine review, which is the current standard of care. The user interface is minimal, consisting of the radiologist's existing picture archiving and communication system (PACS) viewer and worklist in which positively identified images are flagged by the software to notify of the suspected anomaly. Images are not marked or otherwise altered, and no diagnoses are provided.
The device does not have any direct accessories. However, it interacts with hospital communication and database systems in order to read and analyze cases in the worklist of the hospital's PACS system in order to identify suspected abnormal findings and transmit corresponding notifications to reflect its recommended prioritization of patient examinations for radiologist review. The software output is compatible with any PACS viewer and worklist.
Ask a Question
K Number
K120161Device Name
ALPHAPOINT IMAGING SOFTWARE
Manufacturer
RADLOGICS, INC.
Date Cleared
2012-04-13
(85 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RADLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AlphaPoint software is a device that allows review, analysis, and interchange of CT chest images. It is intended for use with CT Chest images to assist medical professionals in image analysis. It is not intended to be the primary interpretation. The software provides segmentation and Hounsfield numerical analysis values which are indicative of various substances (i.e., air, lung, soft tissue, fat, water, transudate, exudate, blood, muscle and bone). The user can review, verify and correct the results of the system and generate a report of the findings.
Device Description
The AlphaPoint system provides a full application framework with integration to PACS using DICOM. The system has the following functions:
- Communicates with PACS to get imaging studies for processing; .
- Activates one or more applications that process the imaging data . and use segmentation and Hounsfield measurements algorithms to find and measure various attributes in the images, and also identify particular slices as references images for the findings ;
- Formats the processing results for each study into a Preliminary . Findings Report
- Sends the results to PACS. .
- The software is written in C++, C# and Matlab. .
Ask a Question
Page 1 of 1