Search Results
Found 1 results
510(k) Data Aggregation
K Number
K181704Device Name
Transpara
Manufacturer
ScreenPoint Medical BV
Date Cleared
2018-11-21
(147 days)
Product Code
QDQ
Regulation Number
892.2090Why did this record match?
Applicant Name (Manufacturer) :
ScreenPoint Medical BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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™.
Device Description
Transpara™ is a software-only device for aiding radiologists with the detection and diagnosis of breast cancer in mammograms. The product consists of a processing server and an optional viewer. The software applies algorithms for recognition of suspicious calcifications and soft tissue lesions, which are trained with large databases of biopsy proven examples of breast cancer, benign lesions and normal tissue. Processing results of Transpara™ can be transmitted to external destinations, such as medical imaging workstations or archives, using the DICOM mammography CAD SR protocol. This allows PACS workstations to implement the interface of Transpara™ in mammography reading applications.
Transpara™ automatically processes mammograms and the output of the device can be used by radiologists concurrently with the reading of mammograms. The user interface of Transpara™ has different functions:
a) Activation of computer aided detection (CAD) marks to highlight locations where the device detected suspicious calcifications or soft tissue lesions. Only the most suspicious soft tissue lesions are marked to achieve a very low false positive rate.
b) Regions can be queried using a pointer for interactive decision support. When the location of the queried region corresponds with a finding of Transpara™ a suspiciousness level of the region computed by the algorithms in the device is displayed. When Transpara™ has identified a corresponding region in another view of the same breast this corresponding region is also displayed to minimize interactions required from the user.
c) Display of the exam based Transpara™ Score which categorizes exams on a scale of 1-10 with increasing likelihood of cancer.
Transpara™ is configured as a DICOM node in a network and receives its input images from another DICOM node, such as a mammography device or a PACS archive. The image analysis unit includes machine learning components trained to detect calcifications and soft tissue lesions and a component to pre-process images in such a way that images from different vendors can be processed by the same algorithms.
Ask a Question
Page 1 of 1