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FDA-cleared K223556

DeepCatch

MEDICALIP Co., Ltd

DeepCatch analyzes whole-body CT images to segment skin, bone, muscle, visceral fat, subcutaneous fat, internal organs, and central nervous system structures, then calculates volumes, proportions, and three-dimensional models for physician confirmation.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2023-06-16
FDA-cleared K191026

MEDIP PRO

MEDICALIP Co., Ltd

Authorized purpose: MEDIP PRO is a software interface and image-segmentation system for transferring DICOM imaging information from a medical scanner to an output file and for preoperative treatment planning. Three-dimensional printed models generated from the output file are intended for non-diagnostic use, and the software is to be used with other diagnostic tools and expert clinical judgment.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Anatomy represented in CT or MR DICOM images for preoperative treatment planning
Decision
2019-11-07