510(k) · Cleared
ClearedMuscleView
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Springbok, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 1, 2024 as substantially equivalent to K173749 (Amra Medical AB, 2018) after a 144-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.
- Decided
- Oct 1, 2024
- Review
- 144 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K173749 (2018). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K251682MuscleView 2.0Springbok, Inc. (Dba Springbok Analytics) · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K173749 | AMRA Profiler | Amra Medical AB | 2018 | — |
| 0 (this device) | K241331 | MuscleView | Springbok, Inc. | 2024 | — |
| +1 | K251682 | MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K173749 | AMRA ProfilerSummary page 6…ion Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Device Class: Class II Product Code: LNH 510(k) Number: K173749 510(k) Clearance Date: Dec 06, 2018 4. Device Description MuscleView is a software only product that uses a machine l… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251682 | MuscleView 2.0 | 2025 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K251682 (Springbok, Inc. (Dba Springbok Analytics), 2025) has gone furthest, with 0 descendants of its own.
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. 2024, 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?
MuscleView is used in adults and pediatrics aged 18 and older to automatically segment muscle and bone structures of the lower extremities from magnetic resonance imaging using a machine learning-based approach. After segmentation, it can provide derived metrics including muscle volume, bone volume, intramuscular fat percentage, and left/right asymmetry. It is intended to be used by physicians who are trained to interpret MRI images, and serves as an…
Read the full statement (136 words)
MuscleView is used in adults and pediatrics aged 18 and older to automatically segment muscle and bone structures of the lower extremities from magnetic resonance imaging using a machine learning-based approach. After segmentation, it can provide derived metrics including muscle volume, bone volume, intramuscular fat percentage, and left/right asymmetry.
It is intended to be used by physicians who are trained to interpret MRI images, and serves as an initial method to segment muscle and bone structures from one or more study series. The segmentation results need to be reviewed and edited using appropriate software.
It is intended to only provide the segmentation and derived metrics for muscle and bone structures and cannot serve as direct guidance for diagnosis of any diseases. This device is not intended for use with patients who have tumors in lower limb.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241331: MuscleView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241331
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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