Rayvolve PTX-PE

K243808

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

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients 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: sensitivity; specificity; AUC; performance time

Reported performance (6 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)”
specificity0.9178CI 0.8911; 0.9561
source quote (p.16)
“high specificity (0.9178, 95% Confidence interval (CI): 0.8911; 0.9561)”
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)”
sensitivityas written: “Sensitivity (Pleural Effusion)”0.9134CI 0.8874; 0.9339
source quote (p.16)
“Detects pleural effusion with high sensitivity (0.9134, 95% Confidence Interval (CI): 0.8874; 0.9339)”
specificityas written: “Specificity (Pleural Effusion)”0.9448CI 0.9239; 0.9339
source quote (p.16)
“high specificity (0.9448, 95% Confidence Interval (CI): 0.9239; 0.9339)”
aurocas written: “AUC (Pleural Effusion)”0.983CI 0.9778; 0.9880
source quote (p.16)
“high area under the Curve (AUC) of the Receiver Operating Characteristic (ROC) (0.9830, 95% Confidence Interval (CI): 0.9778; 0.9880)”

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
1
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243808