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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
Critical Care Suite 2.1, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution
- 00195278789365 ()
- X-ray image interpretive software
The SpassageQ is a SaMD that automatically calculates the patient’s qSOFA score based on the six vital signs received from the HL7 gateway system and the GCS directly entered by the healthcare provider and notifies the user of signs of sepsis through visual alarms.
Spass Co.,Ltd.
1.0.0
In Commercial Distribution
- 08809957910002 ()
- Physiologic monitor-installed 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
V2.11
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
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
No Description
BIOFOURMIS SINGAPORE PTE. LTD.
2.0
In Commercial Distribution
- 08885018690021 ()
- Physiologic monitor-installed 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 wireless Enfasmart FeverSense 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.
VV220
In Commercial Distribution
- 00865064000164 ()
- Wireless patient thermometer, reusable