AIMI-Triage CXR PTX

K193300

RADLogics, Inc. · cleared 2020-04-08 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes case-level output available to a PACS/workstation for worklist prioritization or triage. Identification of suspected cases of moderate to large sized pneumothorax is not for diagnostic use beyond notification.”
Algorithmartificial intelligence algorithm, trained via pattern recognition
source quote (p.4)
“The artificial intelligence algorithm, trained via pattern recognition, processes each chest X-ray and flags those that appear to contain a moderate to large sized pneumothorax for urgent radiologist review.”
Adaptive (vs locked)No
source quote (p.5)
“The algorithms function similarly and with the same purpose of signaling potential pneumothorax without providing diagnosis or altering the original datasets.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=300 images

Reported performance (4 observations)

sensitivity0.92CI [86%, 96%]
source quote (p.5)
“The sensitivity and specificity of the device was 92% (95% CI: [86%, 96%]) and 90% (95% CI: [84%, 95%]), respectively.”
specificity0.9CI [84%, 95%]
source quote (p.5)
“The sensitivity and specificity of the device was 92% (95% CI: [86%, 96%]) and 90% (95% CI: [84%, 95%]), respectively.”
aurocas written: “auc”0.967CI [95.0%, 98.4%]
source quote (p.5)
“Overall, the device was able to demonstrate an area under the curve (AUC) of 96.7% (95% CI: [95.0%, 98.4%]), which is substantially equivalent to the predicate device, and meets the required performance goal.”
time_to_resultas written: “average time to analyze”20.3
source quote (p.5)
“In addition, the average time it takes the AIMI-Triage CXR PTX to analyze the study and send notification to the PACS worklist was measured to be 20.3 seconds, a timing performance that is substantially equivalent to the predicate (22.1 seconds).”

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
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/K193300