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The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV200
In Commercial Distribution
- 00865064000119 ()
- Wireless patient thermometer, reusable
Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Aortic calcification or Dilated aorta.
Aorta-CAD is intended for use as a concurrent reading aid for physicians looking for ROIs with radiographic findings suggestive of Aortic Atherosclerosis or Aortic Ectasia. It does not replace the role of the physician or of other diagnostic testing in the standard of care. Aorta-CAD is indicated for adults only.
Imagen Technologies, Inc.
1.0.0
In Commercial Distribution
- 00852491008030 ()
- X-ray image interpretive software
Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016
Imagen Technologies, Inc.
1.0.0
In Commercial Distribution
- 00852491008023 ()
- X-ray image interpretive software
FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.
Imagen Technologies, Inc.
1.0.0
In Commercial Distribution
- 00852491008016 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
2.2
In Commercial Distribution
- B720BX360ELUNG220 ()
- X-ray image interpretive software
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.
Mirion Technologies (capintec), Inc.
5430-30154
In Commercial Distribution
- 00859942006423 ()
5430-30154
- Thyroid-uptake nuclear medicine system
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, Bioassay module, Wipe Test Module, and Lab Tests.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid System with Well
In Commercial Distribution
- 00859942006102 ()
5430-30152
- Thyroid-uptake nuclear medicine system
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake System
In Commercial Distribution
- 00859942006096 ()
5430-30151
- Thyroid-uptake nuclear medicine system
Thyroid Uptake System, Well Counter
BIODEX MEDICAL SYSTEMS, INC.
187-602
In Commercial Distribution
- 00718175000137 ()
187-602
- Thyroid-uptake nuclear medicine system
Thyroid Uptake System, AtomLab 960, 230 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-601
In Commercial Distribution
- 00718175000021 ()
187-601
- Thyroid-uptake nuclear medicine system
Thyroid Uptake System, AtomLab 960, 120 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-600
In Commercial Distribution
- 00718175000014 ()
187-600
- Thyroid-uptake nuclear medicine system
The Bluetooth Wearable Thermometer is an electronic thermometer using a sensor to measure right
armpit temperature. Its operation is based on measuring the natural thermal radiation emanating
from the armpit and the adjacent surfaces. Its software performs a calculation that factors in room
temperature, and then a calculated temperature is displayed on the mobile device.
Purpose of measuring body temperature is to check body condition by measuring correct
temperature in important part of body and both measured room temperature and relative humidity
are to show environmental conditions.
In case of right armpit measurement, this product searches the highest temperature from the right
armpit.
HuBDIC Co., Ltd.
HMT-100
In Commercial Distribution
- 08800132200413 ()
- Wireless patient thermometer, reusable
No Description
GE Healthcare Austria GmbH & Co OG
16
In Commercial Distribution
- 00840682102780 ()
- Ultrasound imaging system operation software
No Description
GE Healthcare Austria GmbH & Co OG
18
In Commercial Distribution
- 00840682137621 ()
- Ultrasound imaging system operation software
No Description
GE Healthcare Austria GmbH & Co OG
17
In Commercial Distribution
- 00840682122788 ()
- Ultrasound imaging system operation software
No Description
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution
- 00840682146340 ()
- X-ray image interpretive software
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over).
AZMED
4
In Commercial Distribution
- 03770018071084 ()
- X-ray image interpretive software
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over).
(Variant : Full Cloud)
AZMED
4
In Commercial Distribution
- 03770018071077 ()
- X-ray image interpretive software
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over).
(Variant : VM + Cloud)
AZMED
4
In Commercial Distribution
- 03770018071060 ()
- X-ray image interpretive software
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only.
Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types.
(Variant : Cloud/VM)
AZMED
2
In Commercial Distribution
- 03770018071022 ()
- X-ray image interpretive software
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only.
Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types.
(Variant : Full Cloud)
AZMED
2
In Commercial Distribution
- 03770018071015 ()
- X-ray image interpretive software
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only.
Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types.
(Variant : On premise)
AZMED
2
In Commercial Distribution
- 03770018071008 ()
- X-ray image interpretive software
A wearable, battery-powered, electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for recording and data display; it is typically used to monitor temperature during daily activities and sleep. It is in the form of an adhesive patch designed to be placed on the skin (typically in/near the armpit); a charging case and software may be included. This is a reusable device.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
KD-3120.CVS
In Commercial Distribution
- 40050428459506 ()
- 00050428459508 ()
- Wireless patient thermometer, reusable
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.
1.7.y
In Commercial Distribution
- 08719326450131 ()
- X-ray image interpretive software
The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms from compatible FFDM
systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications, region based scores, displayed upon the physicians query, indicating the likelihood that cancer is present in specific regions, and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara.
Screenpoint Medical B.V.
1.5.0 2D
In Commercial Distribution
- 08719326450124 ()
- X-ray 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.
1.x.y
In Commercial Distribution
- 08719326450117 ()
- X-ray image interpretive software
The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications; region‐based scores, displayed upon the physician’s query, indicating the likelihood that cancer is present in specific regions; and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara.
Screenpoint Medical B.V.
1.3.y
In Commercial Distribution
- 08719326450100 ()
- X-ray 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
- 08720387058051 ()
- X-ray 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.
1.7.2
In Commercial Distribution
- 08720387058013 ()
- X-ray image interpretive software
StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients.
NICo-Lab B.V.
1
In Commercial Distribution
- 08720299502352 ()
- X-ray image interpretive software