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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
- 08720387058044 ()
- X-ray image interpretive software
No Description
GLEAMER
1.0.X
In Commercial Distribution
- 03770020839108 ()
- Radiological PACS software
ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.
ClariPI Inc.
1.1.7
In Commercial Distribution
- 08800046800013 ()
- Radiology DICOM image processing application software
FEops HEARTguide ALPACA
FEops
3.1.0
In Commercial Distribution
- 05430002070087 ()
05430002070087
- Radiology DICOM image processing application software
FEops HEARTguide ALPACA 3.0.1 / 3.0.2
FEops
3.0.1
Not in Commercial Distribution
- 05430002070063 ()
- Radiology DICOM image processing application software
No Description
ULTROMICS LIMITED
Core 2.0
In Commercial Distribution
- 05060634690027 ()
- Radiology DICOM image processing application software
- Cardiac mapping system application software
- Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Core
In Commercial Distribution
- 05060634690003 ()
- Radiology DICOM image processing application software
- Cardiac mapping system application software
- Ultrasound imaging system application software
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied
upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology.
IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present.
IB Lab GmbH
V1.06
In Commercial Distribution
- 09120105730730 ()
- X-ray image interpretive software
Brainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment in the context of minimally invasive cranial neurological procedures.
Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc.
Guide XT is compatible with selected Boston Scientific leads and implantable pulse Generators but does not directly interact with the surgeon.
Brainlab AG
3.0
In Commercial Distribution
- 04056481142032 ()
- Implantable electrical stimulation device management software
AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE
Medipixel
V1.0.0
In Commercial Distribution
- 08800127400040 ()
- Radiology DICOM image processing application software