# K251682: MuscleView 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Springbok, Inc. (Dba Springbok Analytics)
- Decided: Sep 9, 2025 after 102 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 K173749 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241331: MuscleView, Springbok, Inc. (2024) Summary page 6.

## Indications for use
MuscleView 2.0 is a magnetic resonance diagnostic software device used in adults and pediatrics aged 18 and older which automatically segments muscle, bone, fat and other anatomical structures from magnetic resonance imaging. After segmentation, it enables the generation, display and review of magnetic resonance imaging data. The segmentation results need to be reviewed and edited using appropriate software. Other physical parameters derived from the images may also be produced. This device is not intended for use with patients who have tumors in the trunk, arms and/or lower limb(s). When interpreted by a trained clinician, these images and physical parameters may yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K251682
Methodology: https://510kreport.com/methodology