Skip to content

MuscleView 2.0

by Springbok, Inc. (Dba Springbok Analytics)

510(k) K251682

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251682 Date9 Sep 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

MuscleView 2.0 is a nuclear magnetic resonance imaging system classified under product code LNH and regulation number 892.1000. It is a radiology device that processes MRI data to provide analysis of muscle, bone, and fat tissue, including measurements of muscle volume, fat infiltration, and symmetry with pixel-level precision.

The device is supplied as a software system for use in clinical radiology settings. It requires connection to MRI scanners to acquire imaging data and is intended for use by trained healthcare professionals. The device received FDA 510(k) clearance under submission K251682, with a final decision date of September 9, 2025, and is classified as a Class II medical device.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is MuscleView 2.0 used for?

    MuscleView 2.0 processes MRI data to provide analysis of muscle, bone, and fat tissue, including measurements of muscle volume, fat infiltration, and symmetry with pixel-level precision, intended for use by trained healthcare professionals in clinical radiology settings.

  • How is MuscleView 2.0 supplied and what is required for its use?

    MuscleView 2.0 is supplied as a software system that requires connection to MRI scanners to acquire imaging data and is intended for use by trained healthcare professionals in clinical radiology settings.

  • What regulatory pathway was used for MuscleView 2.0 and what is its classification?

    MuscleView 2.0 received FDA 510(k) clearance under submission K251682 with a final decision date of September 9, 2025, and is classified as a Class II medical device under product code LNH and regulation number 892.1000.