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510(k) Data Aggregation
K Number
K210916Device Name
PVmed Contouring Software
Manufacturer
Date Cleared
2021-12-03
(249 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Perception Vision Medical Technologies LTD.CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PV med Contouring Software is a software package. It allows the display, annotation, volume operation, volume rendering, and fusion of medical CT images as an aid during use by radiation therapy planning. it is limited to autocontouring of OARs for head and neck, chest and abdomen, abdomen and pelvis.
Device Description
The device, PVmed Contouring Software is a software package. It allows the display, annotation, volume operation, volume rendering, and fusion of medical CT images as an aid during use by radiation therapy planning. it is limited to auto-contouring of OARs for head and neck, chest and abdomen, abdomen and pelvis.
The product mainly has the following image processing functions:
Support contour drawing of organs at risk in head and neck, chest and abdomen, abdomen and pelvis.
It also has the following general functions:
- Receive, add/edit/delete, transmit, input/export, medical images and DICOM data;
- Data set management, patient data management;
- Review of processed images;
- Image fusion;
- Open and Save of files.
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