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510(k) Data Aggregation
K Number
K242647Device Name
MySegmenter (v2.0.0)
Manufacturer
MySegmenter Technologies Inc.
Date Cleared
2025-04-16
(225 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MySegmenter Technologies Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MySegmenter (v2.0.0) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended for surgical planning or educational purposes but are not to be used in the operating room.
The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications.
Device Description
MySegmenter (v2.0.0) is a software platform for visualizing medical images in 3D mesh format. processes images by analyzing the luminance of individual pixels to segment and highlight the regions of interest (specific anatomical areas). MySegmenter supports editing, modification and manipulation of segmented areas using various segmentation tools. The software features include:
- Importing medical images in DICOM and other formats.
- Viewing and navigating through DICOM images.
- Segmenting selected regions using generic tools (segments, island effects, Boolean operations, etc.)
- Editing segments with multiple slice edits, fast marching, watershed effects, etc.
- Generating editable 3D STL files for different applications.
- Converting the segment to mesh models.
- Exporting the segmented models in STL format suitable for further manipulation and manufacturing.
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