MEDIP PRO
MEDICALIP Co., LtdMEDIP PRO is a medical imaging software that helps clinicians by processing CT and MRI images. It provides tools for segmenting images, improving image quality, and creating 3D reconstructions that can be exported for 3D printing to aid in preoperative planning. The software is intended to be used alongside other diagnostic tools and clinical judgement to support treatment planning.
Intended Use
MEDIP PRO is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning. The 3D printed models generated from the output file are meant for non-diagnostic use. MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement.
Technology
MEDIP PRO is medical image processing software providing 3D reconstruction and visualization of regions of interest, image quality improvement, auto segmentation for specific targets, texture analysis, and exports STL data for 3D printing. It supports CT and MRI DICOM inputs and operates as stand-alone software for treatment planning.
Performance
The device underwent software validation per FDA guidance, including subsystem verification and full system validation. Comparative performance tests against the predicate device were conducted for segmentation and measurement functions using phantom studies and usability tests. No clinical studies were performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/18/2019
6 months - 2
FDA Approval
11/7/2019
Other devices from MEDICALIP Co., Ltd
- DeepCatch2023 • 510K
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