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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
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
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
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
GE Healthcare Austria GmbH & Co OG
16
In Commercial Distribution
- 00840682102780 ()
- 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
No Description
GE Healthcare Austria GmbH & Co OG
18
In Commercial Distribution
- 00840682137621 ()
- Ultrasound imaging system operation software