FDA-cleared profile
Momentum Health Inc. · Optical Surface Imaging · FDA-cleared (510(k))
Authorized purpose: The Momentum Spine optical-contour-sensing mobile application quantifies asymmetries and assesses body angles and curve progression related to postural asymmetries, including scoliosis. It is available over the counter or by prescription for patients aged 8 years and older.
Overview status: Source-reviewed overview
Workflow role has not yet been reviewed for this navigation pilot.
A tag identifies a documented role; it does not establish compatibility or local acceptance. Methods and sources
Clinical takeaway. Clinical role: The Momentum Spine optical-contour-sensing mobile application quantifies asymmetries and assesses body angles and curve progression related to postural asymmetries, including scoliosis. It is available over the counter or by prescription for patients aged 8 years and older.
Evidence takeaway. Evidence from the reviewed source record: K232023 FDA decision material identifies the exact optical contour sensing mobile application, labeled use, and submission-specific verification or approval evidence. It does not establish product-wide sensitivity, specificity, outcomes, or independent clinical validation beyond the exact evidence summarized here.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.
Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K232023
The FDA summary states that the device is a screening tool and is not intended to provide definitive diagnosis or replace physician opinion.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Price not public here; enter your quote
Not publicly available: Reviewed sources do not publish an exact-product procurement price with a stated offer scope.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. Build a local total-cost and value model and verify payer, site-of-service, coding, and coverage assumptions independently.
Match the AI release, system build, configuration and region. Source documentation does not establish acceptance of an installed system.
No specific system/version pairing has completed review for this FDA record. A broad DICOM or product-family statement does not establish a named viewer build's support.
Agree the evidence and acceptance owner with your team and suppliers. Checkmarks apply to this page only and are not acceptance receipts.
This is the release-level boundary described in the exact FDA package; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence.
This is the interface boundary described in the exact FDA package; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.
This is buyer-facing monitoring guidance derived from the exact cleared or authorized scope; it is not a claim that the FDA package provides a live monitoring service.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K232023 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared or authorized release includes them.
The FDA package describes a mobile application available directly to lay users or prescribed by physicians; current mobile platform, hosting, account, data-retention, availability, security, and support details remain unverified.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
The FDA package describes a mobile-device video input, 3D torso reconstruction, predicted Cobb angle and asymmetry outputs, and use by lay users or healthcare professionals; current identity, export, routing, archive, and interface behavior require local testing.
exact submission · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Use is limited to patients aged 8 years and older and the labeled screening or monitoring scope; the device is not intended to provide a definitive diagnosis or replace physician opinion.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
Monitor K232023 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Use is limited to patients aged 8 years and older and the labeled screening or monitoring scope; the device is not intended to provide a definitive diagnosis or replace physician opinion.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. optical contour sensing mobile application limits remain submission-specific.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Two trial records name Momentum Spine, but neither states the tested application version or links it to the K232023 configuration; both records are quarantined and none is promoted. The current discovery snapshot contains 0 PubMed and 2 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, fda decision material, fda pma record, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Recorded state, verification date, notes and sources for fields without a publishable value. Conflicting records stay explicitly unsettled here; no plain settled value is shown for them.
No public list price for the exact cleared or authorized configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
6 sources - 3 history items
Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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