Fibresolve (with PCCP)
K252041Imvaria, Inc. · cleared 2025-11-07 · product code QWO · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“Fibresolve is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected cases of interstitial lung disease (ILD).”
Algorithmensemble 3D deep learning model developed and trained using images from multiple facilities
source quote (p.7)
“The Fibresolve Model Inference Graph, the core component of the Analysis System, is an ensemble 3D deep learning model developed and trained using images from multiple facilities.”
Adaptive (vs locked)Yes
source quote (p.11)
“The plan allows for modifications and updates to the underlying Analysis Algorithm within a limited scope of changes, specifically model architecture modification, introduction of new training data, and incorporation of ancillary inputs (while maintaining original inputs).”
PCCPYes
source quote (p.11)
“Fibresolve includes a predetermined change control plan (PCCP), detailing the specific modifications (SaMD Pre-Specifications (SPS)) that may be made to the device and the specific methods in place to achieve and appropriately control the risks of the anticipated types of modifications (Algorithm Change Protocol (ACP)).”
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Bench
sample size not stated
standards: IEC 62304
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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
0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).