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510(k) Data Aggregation
K Number
K212887Device Name
RTapp
Manufacturer
Date Cleared
2021-11-10
(61 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SegAna, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RTapp™ is a stand-alone software that provides a means for comparison of imaging data that is DICOM compliant. It allows the registration and display of medical images as an aid during use by radiation oncology.
Device Description
RTapp™ v2.0 is a stand-alone software medical device. RTapp analyzes and visualizes the day-to-day variations in a radiation therapy patient's individual anatomical structures and the effect of those changes on the treatment dose; it is an aid during use by radiation oncology.
The RTapp software:
- Automatically queries and retrieves treatment plan data and images from any DICOM compliant equipment.
- Automatically processes all patient's treatment fractions, flagging and presenting an advance warning of treatment plans at risk with an email notification.
- Monitors and evaluates treatment plan performance in real time by using the Plan Performance Dose Volume Histogram (DVH). The DVH projects the amount of dose to be delivered.
- Displays Deformable Image Registration contours, cross correlation metrics and flagging of large deformations.
- Projects when Organs At Risk will exceed dose constraints.
- Dose estimation
- Generates reports as PDF with images and graphs.
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