qXR-PTX-PE

K230899

Qure.ai Technologies · cleared 2023-08-22 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“qXR-PTX-PE is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). qXR-PTX-PE uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, qXR-PTX-PE does not send a proactive alert directly to the appropriately trained medical specialists. qXR-PTX-PE is not intended to direct attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The qXR-PTX-PE is a software only device, similar to the predicate (Lunit INSIGHT CXR Triage).”
Algorithmartificial intelligence algorithm
source quote (p.3)
“qXR-PTX-PE uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=613 scans

endpoints: AUC; Sensitivity; Specificity

Retrospective clinical

n=1,070 scans

endpoints: AUC; Sensitivity; Specificity

Reported performance (9 observations)

sensitivity0.9622CI 93.62-97.97
source quote (p.10)
“sensitivity 96.22 (93.62-97.97)”
specificity0.9636CI 94.07-97.95
source quote (p.9)
“Specificity 96.36 (94.07-97.95)”
aurocas written: “auc”0.9894CI 0.9829, 0.9980
source quote (p.8)
“AUC: 0.9894 (95% CI: [0.9829, 0.9980])”
sensitivityas written: “Sensitivity (Pneumothorax)”0.9453CI 90.42-97.24
source quote (p.9)
“Sensitivity 94.53 (90.42-97.24)”
specificityas written: “Specificity (Pneumothorax)”0.9636CI 94.07-97.95
source quote (p.9)
“Specificity 96.36 (94.07-97.95)”
aurocas written: “AUC (Pneumothorax)”0.9894CI 98.28 - 99.82
source quote (p.9)
“AUC 98.94 95% CI (98.28 - 99.82)”
sensitivityas written: “Sensitivity (Pleural Effusion)”0.9622CI 93.62-97.97
source quote (p.10)
“sensitivity 96.22 (93.62-97.97)”
specificityas written: “Specificity (Pleural Effusion)”0.949CI 93.04-96.39
source quote (p.10)
“specificity 94.90 (93.04-96.39)”
aurocas written: “AUC (Pleural Effusion)”0.989CI 98.47 - 99.44
source quote (p.10)
“AUC 98.90 (98.47 - 99.44)”

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) K231805 (decision 2023-12-22) from Qure.ai Technologies for a matching device line ("qXR-LN") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231805

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/K230899