Rayvolve LN

K243831

AZmed · cleared 2025-03-26 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Rayvolve LN is a computer-aided detection software device to assist radiologists to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30mm size.”
Algorithmdeep learning techniques, Supervised Deep learning
source quote (p.7)
“It is a standalone software that uses deep learning techniques to detect and localize pulmonary nodules on chest X-rays.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

n=2,181 images

endpoints: sensitivity; specificity; Area Under The Curve (AUC) of the Receiver Operating Characteristic (ROC)

Reader study (MRMC)

n=400 cases

endpoints: AUC of the ROC curve; sensitivity per image; specificity per image; Alternative Free Response Receiver Operating Characteristic (AFROC); False Positives Per Image; sensitivity per nodule; Time

Reported performance (3 observations)

sensitivity0.8847CI 0.8638; 0.9028
source quote (p.11)
“The results of standalone testing at image level demonstrated that Rayvolve LN detects pulmonary nodules with sensitivity (0.8847, 95% Wilson's Confidence Interval (CI): 0.8638; 0.9028)”
specificity0.8294CI 0.8066; 0.9028
source quote (p.11)
“specificity (0.8294; 95% Wilson's CI: 0.8066; 0.9028)”
aurocas written: “auc”0.8408CI 0.8272; 0.8548
source quote (p.11)
“Area Under The Curve (AUC) of the Receiver Operating Characteristic (ROC) (0.8408; 95% Bootstrap CI: 0.8272; 0.8548).”

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
-100%
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); 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/K243831