qXR-BT

K212690

Qure.ai Technologies · cleared 2021-12-21 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“qXR-BT is a standalone image analysis software used during the review of digital chest radiographic images, intended to facilitate determining the position of tip of the breathing tube relative to the carina.”

Algorithmpre-trained convolutional neural networks (CNNs)

source quote (p.5)

“The qXR-BT analysis module consists of a set of pre-trained convolutional neural networks (CNNs), that form the core processing component shown in Figure 1.”

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)

Bench

n=162 images

endpoints: localization accuracy for the 2 target structures - carina and tip of breathing tube; accuracy of distance measurement between these 2 structures

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

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) K251934 (decision 2026-01-16) from Qure.Ai Technologies for a matching device line ("qXR-Detect") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.
first seen 2026-07-08 · k_number:K251934
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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K231149 (decision 2023-09-22) from Qure.ai Technologies for a matching device line ("qXR-CTR") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231149
re_clearance
The FDA AI/ML device list shows a newer 510(k) K230899 (decision 2023-08-22) from Qure.ai Technologies for a matching device line ("qXR-PTX-PE") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K230899

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).