ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for DeepXray Spina; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08FDA-cleared profile
DeepXray Spina
Alpha Intelligence Manifolds, Inc.
Authorized purpose: Opportunistic review of frontal lumbar-spine or KUB radiographs in adults aged 50 years and older to flag possible low bone mineral density at L1-L4 for clinician follow-up; a negative result does not rule out low BMD.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Opportunistic review of frontal lumbar-spine or KUB radiographs in adults aged 50 years and older to flag possible low bone mineral density at L1-L4 for clinician follow-up; a negative result does not rule out low BMD.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Opportunistic review of frontal lumbar-spine or KUB radiographs in adults aged 50 years and older to flag possible low bone mineral density at L1-L4 for clinician follow-up; a negative result does not rule out low BMD.
- Which images or clinical context are in scope? Modality: X-ray/Radiography Anatomy or clinical context: Spine/Bone Health Input: DeepXray Spina is intended for use with standard frontal radiographs of the lumbar spine or KUB that are suitable for L1–L4 BMD analysis.
- Who uses it? Intended users: Radiologists and/or physician interpreters
- What does the software produce? Output: The device outputs a binary classification: 'Low BMD' (internal L1-L4 T-score 2.5) or 'Not Suspected' (internal L1-L4 T-score > 2.5). A DeepXray Spina report is generated for positive cases only, displaying a vertebral region-of-interest (ROI) overlay on the original radiograph. For negative results, no report is generated. An automated Quality-Control (QC) function detects technical and anatomical exclusion conditions and flags input images with potential quality issues.
- What is its most important limitation? Key limitation: Exclusion criteria: Images in which one or more L1-L4 vertebrae contains: (a) metallic spinal implants or prostheses (e.g., pedicle screws, rods, cages, or total disc replacements); (b) vertebral cement augmentation (e.g., kyphoplasty or vertebroplasty); (c) severe vertebral deformity, fracture, or other structural abnormality that would preclude a valid DXA-based L1-L4 BMD measurement; or (d) extraspinal medical implants overlying the L1-L4 measurement region (e.g., abdominal aortic stent grafts or vascular grafts).
Clinical takeaway
Clinical role: Opportunistic review of frontal lumbar-spine or KUB radiographs in adults aged 50 years and older to flag possible low bone mineral density at L1-L4 for clinician follow-up; a negative result does not rule out low BMD.
Evidence takeaway
Evidence from the reviewed source record: Study type: Stand-Alone Performance. Cases: 1219. Reported sensitivity: 77.0% (95% CI: 72.0%, 81.9%). Reported specificity: 93.6% (95% CI: 92.1%, 95.1%)
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Opportunistic review of frontal lumbar-spine or KUB radiographs in adults aged 50 years and older to flag possible low bone mineral density at L1-L4 for clinician follow-up; a negative result does not rule out low BMD.
- Intended users
- Radiologists and/or physician interpreters
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Research pending
Confirm whether the tool is concurrent reading, triage, post-processing, planning, acquisition support, or another workflow role.
- Required input
- DeepXray Spina is intended for use with standard frontal radiographs of the lumbar spine or KUB that are suitable for L1–L4 BMD analysis.
The exact input restriction states the supported frontal lumbar-spine or KUB radiographs and suitability for L1–L4 BMD analysis; the current generic consultation wording is not packet text.
- Output and human action
- The device outputs a binary classification: 'Low BMD' (internal L1-L4 T-score 2.5) or 'Not Suspected' (internal L1-L4 T-score > 2.5). A DeepXray Spina report is generated for positive cases only, displaying a vertebral region-of-interest (ROI) overlay on the original radiograph. For negative results, no report is generated. An automated Quality-Control (QC) function detects technical and anatomical exclusion conditions and flags input images with potential quality issues.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- Exclusion criteria: Images in which one or more L1-L4 vertebrae contains: (a) metallic spinal implants or prostheses (e.g., pedicle screws, rods, cages, or total disc replacements); (b) vertebral cement augmentation (e.g., kyphoplasty or vertebroplasty); (c) severe vertebral deformity, fracture, or other structural abnormality that would preclude a valid DXA-based L1-L4 BMD measurement; or (d) extraspinal medical implants overlying the L1-L4 measurement region (e.g., abdominal aortic stent grafts or vascular grafts).
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
- FDA submission
- K253192
- Modality
- X-ray/Radiography
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Spine/Bone Health
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- 510(k)
- Decision date
- 2026-06-10
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Research pending
Attach protocol-level DICOM, HL7, FHIR, PACS, RIS, EHR, or orchestrator documentation.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Evidence
Performance 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.
- Evidence summary
- Study type: Stand-Alone Performance. Cases: 1219. Reported sensitivity: 77.0% (95% CI: 72.0%, 81.9%). Reported specificity: 93.6% (95% CI: 92.1%, 95.1%)
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Reported sensitivity
- 77.0% (95% CI: 72.0%, 81.9%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 93.6% (95% CI: 92.1%, 95.1%)
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
DeepXray Spina regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K253192
- Samplen=1219
- IndependenceIndependence not established
K253192
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K253192 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- The exact-identifier FDA recall query returned no native recall record for K253192. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify workflow role: Confirm whether the tool is concurrent reading, triage, post-processing, planning, acquisition support, or another workflow role.
- Verify DICOM, HL7/FHIR, PACS/RIS/EHR integration: Attach protocol-level DICOM, HL7, FHIR, PACS, RIS, EHR, or orchestrator documentation.
- Verify deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K253192 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
23Fields reviewed
10Source classes checked
2Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 2 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 2 PubMed and 0 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, acr ai central product, fda decision summary, fda device recall, literature index, trial registry, fda decision summary packet, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
-
FDA K253192: DeepXray Spina
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, output, limitations, evidenceSummary, input
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
DeepXray Spina model card (K253192)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K253192
Scope: postmarketSafety
Research history
-
K253192 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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