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510(k) Data Aggregation

    K Number
    K230187
    Device Name
    Terran NM-101
    Date Cleared
    2023-09-29

    (249 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Terran Biosciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Terran NM-101 is a post-processing software medical device in visualization of the brain in older adults between the age of 51 to 83 years. Terran NM-101 analyzes input data acquired from Siemens 3T MR imaging systems, using a specified protocol (i.e., Turbo Spin Echo, TSE). Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition. Terran NM-101 is also intended for automatic labeling, volumetric quantification and contrast quantification of segmentable brain tissues from a set of Siemens 37 acquired MR images. Brain tissue characterization and volumes of neuromelanin associated signal contrasts are determined based on analysis of qualitative parametric maps. When interpreted by a neuroradiologist. Terran NM-101 images can provide information useful in determining neuromelanin association as an adjunct to diagnosis. Terran NM-101 must always be used in combination with a T1-weighted image MR acquisition.
    Device Description
    Terran NM-101 is a fully automated post-acquisition software as a medical device (SaMD) that measures neuromelanin associated contrast to noise ratio (CNR) signal in the substantia nigra (SN) and locus coeruleus (LC) regions of non-contrast brain magnetic resonance imaging (MRI) images from Siemens 3 tesla (3T) MRI scanners. Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition.
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