# K230187: Terran NM-101

- Pathway: 510(k) (Traditional)
- Applicant: Terran Biosciences, Inc.
- Decided: Sep 29, 2023 after 249 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K061855 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191036: SyMRI, Syntheticmr AB (2019) Summary page 4.
- K170981: NeuroQuant, Cortechs Labs, Inc. (2017) Summary page 4.

## Indications for use
Terran NM-101 is a post-processing software medical device intended for use 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, visualization, volumetric quantification and contrast quantification of segmentable brain tissues from a set of Siemens 3T 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.

Source page: https://510kreport.com/device/K230187
Methodology: https://510kreport.com/methodology