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The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
2.0
In Commercial Distribution
- 00850894007605 ()
- X-ray image interpretive software
ClearPoint Maestro Brain Model Software Version 1.0
Clearpoint Neuro, Inc.
CPM-SFW-1
In Commercial Distribution
- 00850359007966 ()
CPM-SFW-1
- Image segmentation application software
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans.
qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm.
The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution
- 00850057636000 ()
- Radiology DICOM image processing application software
No Description
EOS IMAGING
2.1
In Commercial Distribution
- 03663999000337 ()
- Basic diagnostic x-ray system application software
No Description
EOS IMAGING
1.0
Not in Commercial Distribution
- 03663999000290 ()
- Basic diagnostic x-ray system application software
This Software as a Medical Device provides a user with automatic contouring of delayed enhancement and ejection fractions studies. Ejection fraction studies are segmented in short axis views for verification and accuracy.
Terarecon Inc.
Cardiac.Chambers.MR01
In Commercial Distribution
- CARDIACCHAMBERSMR1 ()
CARDIACCHAMBERSMR1
- Radiology DICOM image processing application software
No Description
LINKVERSE SRL
4.0.1-S
In Commercial Distribution
- 78055060110375 ()
- 08055060110376 ()
CPRO401S-US
- Endoscopic video image interpretive software
Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution
- 78055060110344 ()
- 08055060110345 ()
CPRO401-US
- Endoscopic video image interpretive software
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution
- 08055060110338 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution
- 08055060110321 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution
- 08055060110314 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
CPRO40.US
In Commercial Distribution
- 78055060110290 ()
- 08055060110291 ()
- Endoscopic video image interpretive software
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution
- 08055060110185 ()
FS01
- Foot-switch, electrical
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution
- 08055060110178 ()
UKS01
- Foot-switch, electrical
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution
- 00190199649293 ()
- Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution
- 00190198909541 ()
- Cardiopulmonary physiological parameter analysis software
ECG Watch App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution
- 00190199649286 ()
- Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution
- 00190198909534 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Philips Ultrasound LLC
Release 15.6
In Commercial Distribution
- 00884838115323 ()
795041
- Radiological PACS software
VM11.0 update
Philips Ultrasound LLC
795041
In Commercial Distribution
- 00884838122277 ()
- Radiological PACS software
No Description
Philips Ultrasound LLC
989605496482
In Commercial Distribution
- 00884838102903 ()
- Radiological PACS software
Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports standard DICOM formats for 2D and 3D image files and enables advanced imaging functionalities for enhanced diagnostic accuracy.
The software provides a range of features, including:
- 2D Imaging: Loading, editing, and viewing 2D dental images in standard formats (e.g., DICOM, JPG, BMP).
- 3D Imaging: Visualization and reconstruction of 3D CT images, including multi-planar views (MPR) and volume rendering.
- Preoperative Planning: Implant position simulation, canal drawing, and bone density analysis to support treatment planning.
- Data Interoperability: Facilitates data transfer and storage using DICOM-compliant workflows, ensuring compatibility with third-party systems and imaging devices.
The software interfaces with dental imaging equipment, such as CT, panoramic, cephalometric, and intraoral X-ray systems, as well as intraoral cameras, for image
acquisition. It is designed for use in network environments, allowing users to upload and download clinical diagnostic images and patient data for enhanced collaboration and efficient patient management.
EWOO SOFT Co., Ltd
1.0
In Commercial Distribution
- 08800019700593 ()
- General-purpose dental x-ray system application software
TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.
Terarecon Inc.
Aorta.CT01
In Commercial Distribution
- AORTACT01 ()
Aorta.CT
- Radiology DICOM image processing application software
SW B36104S SURETUNE4 DBS SERVER
MEDTRONIC, INC.
B36104S
In Commercial Distribution
- 00763000421212 ()
- 00763000496456 ()
- Implantable electrical stimulation device management software
SW B36104C SURETUNE4 DBS CLIENT
MEDTRONIC, INC.
B36104C
In Commercial Distribution
- 00763000421212 ()
- 00763000496449 ()
- Implantable electrical stimulation device management software
SW B36104A SURETUNE4 DBS STANDALONE
MEDTRONIC, INC.
B36104A
In Commercial Distribution
- 00763000421212 ()
- 00763000496432 ()
- Implantable electrical stimulation device management software
No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution
- 17540262150018 ()
- Radiological PACS software
GGI Genius (TM) System 200
Covidien LP
GGS200
In Commercial Distribution
- 10884521844544 ()
- Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;
- Endoscopic video image interpretive unit
GGI Genius (TM) System 100
Covidien LP
GGS100
In Commercial Distribution
- 10884521844537 ()
- Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;
- Endoscopic video image interpretive unit
Intelligent Endoscopy Module , Refurbished
Covidien LP
CB1708-RFB
In Commercial Distribution
- 10884521821545 ()
- Endoscopic video image interpretive unit
Intelligent Endoscopy Module
Covidien LP
CB1708-EU
In Commercial Distribution
- 10884521807259 ()
- Voltage, 100- 240, VAC;+/-10%,50/60,Hertz;Power,240,W;
- Endoscopic video image interpretive unit
SW B36104S SURETUNE4 DBS SERVER MDR
MEDTRONIC, INC.
B36104S
In Commercial Distribution
- 00763000990442 ()
- Implantable electrical stimulation device management software
SW B36104C SURETUNE4 DBS CLIENT MDR
MEDTRONIC, INC.
B36104C
In Commercial Distribution
- 00763000990435 ()
- Implantable electrical stimulation device management software
SW B36104A SURETUNE4 DBS STANDALONE MDR
MEDTRONIC, INC.
B36104A
In Commercial Distribution
- 00763000990428 ()
- Implantable electrical stimulation device management software
POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution
- 18059015375848 ()
TLHEXMODULESW1.1
- Radiological PACS software
PREOPERATIVE JPS MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution
- 18053340345682 ()
JPSMODULESW
- Radiological PACS software
PREOPERATIVE FITBONE MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution
- 18052469470008 ()
FITBONEMODULESW
- Radiological PACS software
FeetMe Evaluation mobileAndroid application version 3.Y.Z.
FEETME
3
In Commercial Distribution
- 03760349820062 ()
- Posturography system application software
Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.
KINESIS
2.0.1
In Commercial Distribution
- 05391542950027 ()
- Posturography system application software
No Description
Balance Tracking Systems Incorporated
Version 7
In Commercial Distribution
- 00860010129111 ()
- Posturography system application software
BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
23.y.z
In Commercial Distribution
- 07290018052297 ()
- Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
22.y.z
In Commercial Distribution
- 07290018052273 ()
- Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
21.x.y
In Commercial Distribution
- 07290018052259 ()
- Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
19.x.y
In Commercial Distribution
- 07290018052211 ()
- Radiology DICOM image processing application software
Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
MOBERG RESEARCH INC
VIS-100
In Commercial Distribution
- B485VIS100 ()
- Bioelectrical signal analysis software
Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
NATUS NEUROLOGY INCORPORATED
1.03.00
In Commercial Distribution
- B485CNSENV1000 ()
- Bioelectrical signal analysis software
software versions 3.6.0, 3.7.0, 3.7.1, 3.8.0, 3.9.0
Annalise Triage (Annalise Critical Care AI) is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.6.0+
In Commercial Distribution
- G140ANNALISEENTP50 ()
AnnaliseENTP5
- X-ray image interpretive software
Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.4.1
In Commercial Distribution
- G140ANNALISEENTP40 ()
- Radiology DICOM image processing application software
Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.3.0
In Commercial Distribution
- G140ANNALISEENTP30 ()
- Radiology DICOM image processing application software
Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.2.0
In Commercial Distribution
- G140ANNALISEENTP20 ()
- Radiology DICOM image processing application software