510(k) · Cleared
ClearedTerran NM-101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terran Biosciences, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 29, 2023 as substantially equivalent to K191036 (Syntheticmr AB, 2019) and 1 other predicate after a 249-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Sep 29, 2023
- Review
- 249 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K061855 (2006). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| −1 | K170981 | NeuroQuant | Cortechs Labs, Inc. | 2017 | — |
| 0 (this device) | K230187 | Terran NM-101 | Terran Biosciences, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191036 | SyMRISummary page 4…The Terran NM-101 is similar to the primary predicate device SyMRI cleared for US commercialization via K191036, on 6/13/2019 and predicate device NeuroQuant cleared for US… | 2019 |
| * | K170981 | NeuroQuantSummary page 4…via K191036, on 6/13/2019 and predicate device NeuroQuant cleared for US commercialization via K170981, on 9/7/2017. 4. DEVICE DESCRIPTION Terran NM-101 is a fully automated post-acquisition software as a… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
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…
Read the full statement (142 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230187: Terran NM-101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230187
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026