MuscleView 2.0

K251682

Springbok, Inc. (dba Springbok Analytics) · cleared 2025-09-09 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“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.”
Algorithmlocked artificial intelligence/machine learning (AI/ML) algorithm
source quote (p.6)
“The software utilizes a locked artificial intelligence/machine learning (AI/ML) algorithm to identify and segment anatomical structures for quantitative analysis.”
Adaptive (vs locked)No
source quote (p.6)
“The software utilizes a locked artificial intelligence/machine learning (AI/ML) algorithm to identify and segment anatomical structures for quantitative analysis.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.9)
“MuscleView 2.0 has been tested in alignment with the FDA's guidance on software functions ("Content of Premarket Submissions for Device Software Functions”, June 14, 2023) and cybersecurity ("Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”, September 27, 2023). It has successfully met the predetermined acceptance criteria for the following tests: ... Cybersecurity Testing”

Validation studies (1)

Retrospective clinical

n=1,294 patients · 19 site(s)

endpoints: dice similarity coefficient (DSC); volume difference (VDt)

Reported performance (1 observation)

diceas written: “Dice Similarity Coefficient (DSC)”stated without valueCI 0.962-0.965
source quote (p.9)
“Validation Tests met the acceptance criteria if the dice similarity coefficient (DSC) or volume difference (VDt) was below interobserver variability, establishing boundaries that reflect clinically acceptable variance among expert human reviewers.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

100
recalls in product code, 24mo
510
MAUDE reports in code, 12mo
+5%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98779

  • recall_reason_pattern

    Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98111

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251682