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No Description
Neosoma, Inc.
3
In Commercial Distribution
- 00860009223646 ()
- Image segmentation application software
No Description
Neosoma, Inc.
2
In Commercial Distribution
- 00860009223639 ()
- Image segmentation application software
No Description
Neosoma, Inc.
2
Not in Commercial Distribution
- 00860009223622 ()
- Image segmentation application software
No Description
Neosoma, Inc.
2.3.2.0
Not in Commercial Distribution
- 00860009223615 ()
- Image segmentation application software
No Description
Neosoma, Inc.
2.1.2.0
Not in Commercial Distribution
- 00860009223608 ()
- Image segmentation application software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution
- 00860009117716 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution
- 00860009117709 ()
- Cardiopulmonary physiological parameter analysis software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution
- 00853341006053 ()
- Vascular modelling software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries.
The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease.
The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 2
In Commercial Distribution
- 00853341006039 ()
- Vascular modelling software
HeartFlow FFRct is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease. FFRct is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation report includes identification of vendors and equipment used in the clinical validation of the product. This data is summarized in the product labeling, and can be found in the Clinical User Instructions for Use. HeartFlow FFRct analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
v2.18
In Commercial Distribution
- 00853341006022 ()
- Vascular modelling software
HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis of
previously acquired Computed Tomography DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and
data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional
information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the
clinician in the assessment of coronary artery disease. HeartFlow FFRct is independent of imaging equipment, imaging protocols
and equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated to
acquisition equipment and workstations.
Heartflow, Inc.
v2.1
In Commercial Distribution
- 00853341006015 ()
- Vascular modelling software
HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries.
The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease.
HeartFlow FFRct is independent of imaging equipment, imaging protocols and equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and workstations.
Heartflow, Inc.
v2.1
In Commercial Distribution
- 00853341006008 ()
- Vascular modelling software
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
ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.
ClariPI Inc.
1.1.7
In Commercial Distribution
- 08800046800013 ()
- Radiology DICOM image processing application 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
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
GLEAMER
1.0.X
In Commercial Distribution
- 03770020839108 ()
- Radiological PACS software
No Description
EOS IMAGING
1.0
Not in Commercial Distribution
- 03663999000290 ()
- Basic diagnostic x-ray system application software
No Description
EOS IMAGING
2.1
In Commercial Distribution
- 03663999000337 ()
- Basic diagnostic x-ray system application software
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution
- 00190199649293 ()
- 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
- 00190198909541 ()
- Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution
- 00190198909534 ()
- Cardiopulmonary physiological parameter analysis 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
No Description
LINKVERSE SRL
4.0.1-S
In Commercial Distribution
- 78055060110375 ()
- 08055060110376 ()
CPRO401S-US
- Endoscopic video image interpretive software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that
cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
2.Y.Z
In Commercial Distribution
- 08720387058044 ()
- X-ray image interpretive 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
No Description
STRYKER CORPORATION
3105001000
In Commercial Distribution
- 07613327382570 ()
3105001000
- Radiology DICOM image processing application software
Viz Subdural+ v1.1 (2025-07-10)
VIZ.AI, INC.
Viz Subdural+ Software
In Commercial Distribution
- 00811852030363 ()
- Radiology DICOM image processing application software
Viz ICH+ v1.3 (2025-04-06)
VIZ.AI, INC.
Viz ICH+ Software
In Commercial Distribution
- 00811852030349 ()
- Radiology DICOM image processing application software
Viz HCM v1.1 (2024-06-19)
VIZ.AI, INC.
Viz HCM Software
In Commercial Distribution
- 00811852030332 ()
- Cardiopulmonary physiological parameter analysis software
Viz RV/LV v1.2 (2023-04-19)
VIZ.AI, INC.
Viz RV/LV Software
In Commercial Distribution
- 00811852030295 ()
- Radiology DICOM image processing application software