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Premier Heart MCG Analysis Cluster software, including:
- MCG Clinical Client (reference implementation and API)
- MCG Webapps/Report Generator
- MCG Clinical Database
- MCG Analysis Engine
PREMIER HEART, LLC
MCGC
In Commercial Distribution
- B320MCGC0 ()
- Cardiopulmonary physiological parameter analysis software
icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria
icometrix NV
1.1
In Commercial Distribution
- B621ICOBRAINARIA1X1Y0 ()
- Radiology DICOM image processing application software
CINA-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.
The Software automatically reorients images, segments and analyzes ASPECTS Regions of lnterest (ROIs). CINA-ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. CINA-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic (acute) brain tissue injury during image interpretation. CINA-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS region definitions and highlighting ROIs and numerical scoring
AVICENNA.AI
1.5
In Commercial Distribution
- B826CINAASPECTS150 ()
- Radiology DICOM image processing application software
Holter Web Portal
Lifesignals, Inc.
UA2251-C
In Commercial Distribution
- B353UA2251C1 ()
- Wireless patient monitor/sensor reporting software, professional-only
GoCheck Kids stand-alone software version 4.4.60 for the Nokia device.
Gobiquity, Inc.
Nokia 4.4.60
GCKNOK
- External ocular measurement camera
MRID 3D (5mm) Image Distortion Analysis System - Phantom and Software
Modus Medical Devices Inc
100-1018-500
In Commercial Distribution
- G34310010185000 ()
- Multi-modality therapeutic radiation phantom, test object
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application.
The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution
- G618000010 ()
- Ultrasound imaging system operation software
- Hand-held ultrasound imaging system, body-surface
- Ultrasound imaging system operator console
iQ-SYSTEM PACS is a software for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.
IMAGE Information Systems Europe GmbH
1.6
In Commercial Distribution
- B403IQS160 ()
- Radiology picture archiving and communication system digital archive device
iQ-SYSTEM PACS is a software for network or web-based medical image viewing and manipulation. It is adoped for storing, processing, routing and reporting.
IMAGE Information Systems Europe GmbH
1.5
In Commercial Distribution
- B403IQS150 ()
- Radiology picture archiving and communication system digital archive device
iQ-SYSTEM PACS is a software for network or web-based medical image viewing and manipulation. It is adopted for storing, processing, routing and reporting.
IMAGE Information Systems Europe GmbH
1.4
In Commercial Distribution
- B403IQS140 ()
- Radiology picture archiving and communication system digital archive device