QIR Suite
K211611CASIS Cardiac Simulation & Imaging Software · cleared 2022-09-30 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.6)
“QIR Suite is a software for quantitative analyses of cardiovascular magnetic resonance images in the DICOM format. Analyses are performed using standardized and deep-learning algorithms. QIR Suite is a medical device software with a "moderate" level of concern”
Algorithmstandard algorithms, and/or automated deep learning detection algorithms
source quote (p.3)
“QIR Suite comprises QIR-MR for analysis of MR images. QIR-MR is composed of a viewer and analysis modules, and uses user inputs, standard algorithms, and/or automated deep learning detection algorithms.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (2)
Retrospective clinical
sample size not stated
endpoints: correlation coefficient R2; absolute mean difference
Standalone
sample size not stated
endpoints: Dice coefficient
Reported performance (3 observations)
diceas written: “Dice coefficient (AG algorithm)”0.893
source quote (p.9)
“DICE measurements performed on large testing datasets gave a mean score of 0.893 and 0.888 for the AG and AG+ algorithms respectively, and 0.908 for the Fast algorithm.”
diceas written: “Dice coefficient (AG+ algorithm)”0.888
source quote (p.9)
“DICE measurements performed on large testing datasets gave a mean score of 0.893 and 0.888 for the AG and AG+ algorithms respectively, and 0.908 for the Fast algorithm.”
diceas written: “Dice coefficient (Fast algorithm)”0.908
source quote (p.9)
“DICE measurements performed on large testing datasets gave a mean score of 0.893 and 0.888 for the AG and AG+ algorithms respectively, and 0.908 for the Fast algorithm.”
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
3
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).