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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
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
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
No Description
BRAINOMIX LIMITED
1.0
In Commercial Distribution
- B720BX360ELUNG100 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution
- B720BX360ECTP1110 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution
- B720BX360ECTA1130 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution
- B720BX360ECTA1110 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution
- B720BX360EASPECTS113 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution
- B720BX360EASPECTS1110 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution
- B720BX360EMRI1110 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
2.1
In Commercial Distribution
- B720BX360ELUNG210 ()
- X-ray image interpretive software
Critical Care Suite 2.1, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution
- 00195278789365 ()
- X-ray image interpretive software
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 MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution
- 00840682146340 ()
- X-ray image interpretive 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
Lunit Inc.
1.1
In Commercial Distribution
- 08800076000162 ()
- X-ray image interpretive software
No Description
Lunit Inc.
1.0
In Commercial Distribution
- 08800076000148 ()
- X-ray image interpretive software
No Description
Lunit Inc.
1.1
In Commercial Distribution
- 08800076000056 ()
- X-ray image interpretive software
No Description
GENORAY CO., LTD.
Zenis
In Commercial Distribution
- 08809244060137 ()
- X-ray image interpretive software
The SMILE-100 System is a breast thermography device with a visualization tool that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It is intended to be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel.
NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED
v4.8.0
In Commercial Distribution
- 08908019450057 ()
NA
- Infrared thermography interpretive software
Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit
temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Temp Pal can be used at home and healthcare center.
iWEECARE Co., Ltd.
STP-MB01-1
In Commercial Distribution
- 04712977931060 ()
- 14712977931067 ()
- Wireless patient thermometer, reusable
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.11
Not in Commercial Distribution
- 09120105730471 ()
- 09120105730464 ()
- X-ray image interpretive software
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.05
Not in Commercial Distribution
- 09120105730082 ()
- 09120105730037 ()
- X-ray image interpretive software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution
- 03770021392114 ()
2001-001
- Patient self-taken medical image communication software
- Clinical management support software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution
- 03760405340251 ()
2001-001
- Patient self-taken medical image communication software
- Clinical management support software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution
- 03760405340244 ()
2001-001
- Patient self-taken medical image communication software
- Clinical management support software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution
- 03760405340237 ()
2001-001
- Patient self-taken medical image communication software
- Clinical management support software
Applications Platform 4.0 INTL – INT KIT – 3 Room
IMRIS Imaging, Inc.
120088-000
In Commercial Distribution
- 00857534006684 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 INTL – INT KIT
IMRIS Imaging, Inc.
120086-000
In Commercial Distribution
- 00857534006677 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 INTL – 3 Room
IMRIS Imaging, Inc.
119898-000
In Commercial Distribution
- 00857534006660 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0-INTL-2-Room
IMRIS Imaging, Inc.
119408-000
In Commercial Distribution
- 00857534006653 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000
IMRIS Imaging, Inc.
Application Platform 4.0 KIT
In Commercial Distribution
- 00857534006646 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – INT KIT-120085-000
IMRIS Imaging, Inc.
Application Platform 4.0- KIT
In Commercial Distribution
- 00857534006639 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – 3 Room- 119897-000
IMRIS Imaging, Inc.
Application Platform 4.0- 3 Room
In Commercial Distribution
- 00857534006622 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000
IMRIS Imaging, Inc.
Application Platform 4.0 2-Room
In Commercial Distribution
- 00857534006493 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Application Platform 2.4 NA
IMRIS Imaging, Inc.
115407-000
In Commercial Distribution
- 00857534006363 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
No Description
Circle Cardiovascular Imaging Inc
6.x
In Commercial Distribution
- 00882916000028 ()
- MRI system application software
- CT system application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- HL7 Integration Engine
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NHL7
In Commercial Distribution
- 07290110252595 ()
HASP-SW-K-NHL7IE-01
- Medical equipment clinical data interfacing software
ExamVue PACS version 1.1 Build 81
TELEVERE SYSTEMS, LLC
1.1 Build 81
In Commercial Distribution
- 00851800007078 ()
ExamVue PACS 1.1 Build 81
- Radiological PACS software
- General-purpose dental x-ray system application software
- Multidisciplinary medical image management software
- Camera application software
- Basic diagnostic x-ray system application software
For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit and display images as a PACS application. In addition it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files
Radiology Information Systems, Inc.
RSVS
In Commercial Distribution
- 00860009490642 ()
- Radiological PACS software
- Radiology picture archiving and communication system digital archive device
Local Hyperthermia System (U.S.A.)
BSD MEDICAL CORPORATION
BSD-500
Not in Commercial Distribution
- 00851551005194 ()
- Microwave hyperthermia system