IQ-UIP
K242467Imbio, 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.”
Algorithmartificial intelligence algorithm, deep learning inference model
source quote (p.6)
“Imbio IQ-UIP uses an artificial intelligence algorithm to analyze images and identify positive findings on a worklist application separate from and in parallel to the standard of care radiological image interpretation. 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 addressedNo
Validation studies (1)
Standalone
n=804 patients
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). 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).