Release and scope verification
Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K252041.
exact submission · checked 2026-09-04FDA-cleared profile
Fibresolve (with PCCP)
Imvaria, Inc.
Fibresolve analyzes lung CT in patients with pulmonary symptoms to provide an adjunct diagnostic-subtype classification for suspected interstitial lung disease and support referral to a multidisciplinary discussion.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Fibresolve analyzes lung CT in patients with pulmonary symptoms to provide an adjunct diagnostic-subtype classification for suspected interstitial lung disease and support referral to a multidisciplinary discussion.
- Intended users
- Clinicians qualified in care of lung disease, including clinicians caring for patients with interstitial lung disease.
- Care setting and population
- Interstitial-lung-disease referral and multidisciplinary discussion workflows.
- Workflow role
- Adjunct lung-CT classification and referral support before invasive testing.
- Required input
- DICOM-compliant lung CT studies from patients aged over 22 years with pulmonary symptoms.
- Output and human action
- A report containing patient and technical information and a binary result suggesting the classified disease pattern.
- Limitations
- The FDA labeling states that Fibresolve is adjunctive, must be used with history, symptoms, other tests, and professional judgment, and is not a replacement for multidisciplinary or invasive evaluation.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The FDA package describes lung CT DICOM input, a cloud image receiver API, image ingestion and analysis, and output through an API to a hospital or clinic workflow.
- Deployment and data flow
- The FDA package describes cloud software and API integration or manual manufacturer submission; current hosting, security, availability, retention, and contractual boundaries remain unknown.
- Security and privacy
- Not established in reviewed sources
Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Training and support
- Use by clinicians qualified in care of lung disease, including clinicians caring for patients with interstitial lung disease. Follow the exact labeling, local training, supervision, and escalation requirements.
- Monitoring and change control
- Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K252041.
Deployment boundary
The FDA package describes cloud software and API integration or manual manufacturer submission; current hosting, security, availability, retention, and contractual boundaries remain unknown.
exact submission · checked 2026-09-04Interoperability acceptance
The FDA package describes lung CT DICOM input, a cloud image receiver API, image ingestion and analysis, and output through an API to a hospital or clinic workflow.
exact submission · checked 2026-09-04Clinical acceptance
Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K252041.
exact submission · checked 2026-09-04Economic evaluation
Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.
product family · checked 2026-09-04Lifecycle monitoring
Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.
exact submission · checked 2026-09-04Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- K252041 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for Fibresolve with PCCP. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
- Reported sensitivity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
- Reported specificity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K252041 FDA evidence package for Fibresolve (with PCCP)
FDA 510(k) decision evidence and product verification for the exact submission. · Lungs and interstitial lung disease patterns
exact submission · Tested version: Fibresolve with PCCP · Sponsor or vendor studyK252041
FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.
Economics and lifecycle
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Not established in reviewed sources
No public list price or commercial contract for the exact submission and version was identified.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
No product-specific code
No exact-product reimbursement determination identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.
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
- No record matched K252041 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Verify pricing and total cost: No public list price or commercial contract for the exact submission and version was identified.
- Verify reimbursement and coding relevance: No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
11Source classes checked
8Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
No evidence was promoted. The records name Fibresolve but do not identify the K252041 with-PCCP configuration or tested build; PMID 42587682 identifies an FDA-authorized product through the earlier DEN220040 record rather than K252041. The current discovery snapshot contains 8 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, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-04.
- FDA 510(k) decision material K252041: Fibresolve (with PCCP) U.S. Food and Drug Administration · 2026-09-04
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- Fibresolve (with PCCP) model card (K252041) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
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