Rayvolve PTX-PE

K243808

AZmed · cleared 2025-03-21 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.8)

“Rayvolve PTX-PE is a software-only device designed to help healthcare professionals. It's a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients of 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax).”

Algorithmartificial intelligence algorithm

source quote (p.4)

“Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides study-level output available in DICOM node servers for worklist prioritization or triage.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Standalone

n=2,000 images

endpoints: Detects pneumothorax with high sensitivity; Detects pleural effusion with high sensitivity; performance time

Reported performance (3 observations)

sensitivity0.9379CI 0.9127; 0.9561

source quote (p.16)

“Detects pneumothorax with high sensitivity (0.9379, 95% Confidence interval (CI): 0.9127; 0.9561)”

specificity0.9448CI 0.9239; 0.9339

source quote (p.16)

“high specificity (0.9448, 95% Confidence Interval (CI): 0.9239; 0.9339)”

aurocas written: “auc”0.9857CI 0.9809; 0.9901

source quote (p.16)

“high area under the Curve (AUC) of the Receiver Operating Characteristic (ROC) (0.9857, 95% Confidence Interval (CI): 0.9809; 0.9901)”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K243831 (decision 2025-03-26) from AZmed for a matching device line ("Rayvolve LN") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243831

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).