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510(k) Data Aggregation
K Number
K220034Device Name
NEUROShield
Manufacturer
Date Cleared
2023-09-14
(617 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
In-Med Prognostics L3C
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NEUROShield™ medical image processing software is intended for automatic labelling, visualization, and volumetric quantification of the Hippocampus brain structure from a set of MR images.
Device Description
NEUROShield™ is a fully automated brain geometry-based quantifying analytics tool/cloud platform that uses Al/Deep Net to support physicians as a clinical decision support tool for neurologists and neuroradiologists. NEUROShield™ takes 3D MR images as input and calculates brain volumes that can assist physicians in devising optimal treatment plans. The Al tool branded as NEUROShield™ provides volumetric measurements of the Hippocampus brain structure. It replaces time-consuming manual processes with leading-edge automated technology that accelerates the analysis for clinical and research purposes. Brain Volume Quantification is a wellestablished methodology for differential and enhanced interpretation of medical images. We are using a locked algorithm, and any proposed modifications will be submitted to the FDA for review.
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