IQ-UIP

K242467

Imbio, Inc. · cleared 2024-12-19 · product code QWO · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Imbio IQ-UIP is a computer-aided software indicated for use in passively notifying specialists associated with interstitial lung disease (ILD) centers of radiological findings suggestive of radiological usual interstitial pneumonia (UIP) in non-contrast, chest CT scans of adults.”
Algorithmdeep learning inference model
source quote (p.6)
“The development of the deep learning inference model utilized anonymized, multi-center, retrospective, volumetric chest CT scans from several different, private and public data sources including multiple hospitals, clinical imaging centers, and imaging databases.”
Adaptive (vs locked)No
source quote (p.6)
“The testing data set was locked and quarantined from the datasets used in the device's model training and validation.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=804 images

endpoints: AUC ROC; PPV; specificity; sensitivity

Reported performance (4 observations)

sensitivity90.2CI [86.2, 94.3]
source quote (p.10)
“For secondary endpoints, the device's specificity is 91.5 [89.2, 93.7] and sensitivity is 90.2 [86.2, 94.3].”
specificity91.5CI [89.2, 93.7]
source quote (p.10)
“For secondary endpoints, the device's specificity is 91.5 [89.2, 93.7] and sensitivity is 90.2 [86.2, 94.3].”
aurocas written: “auc”96.6CI [95.4, 97.7]
source quote (p.10)
“For primary endpoints, the device's AUC ROC is 96.6 [95.4, 97.7] and PPV is 77.9 [73.3, 82.8].”
ppvas written: “PPV”77.9CI [73.3, 82.8]
source quote (p.10)
“For primary endpoints, the device's AUC ROC is 96.6 [95.4, 97.7] and PPV is 77.9 [73.3, 82.8].”

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/K242467