# K241331: MuscleView

- Pathway: 510(k) (Traditional)
- Applicant: Springbok, Inc.
- Decided: Oct 1, 2024 after 144 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: 1 generation back to K173749 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173749: AMRA Profiler, Amra Medical AB (2018) Summary page 6.

## Most influential descendants
- K251682: MuscleView 2.0 (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K241331
Methodology: https://510kreport.com/methodology