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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