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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
Rho radiology software for opportunistic evaluation of low bone mineral density.
16 Bit Inc.
Rho
In Commercial Distribution
- 06287194090220 ()
- X-ray image interpretive software
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
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