Definium Tempo Select
K250788GE Hualun Medical Systems Co., Ltd · cleared 2025-08-28 · product code KPR · Radiology
Premarket evidence — what FDA accepted
Device typehardware with ml
source quote (p.7)
“An update was made to the previously cleared Tissue Equalization feature under K013481 to introduce a Deep Learning Al model that provides more consistent image presentations to the user which reduces additional workflow to adjust the image display parameters. The image processing algorithm uses artificial intelligence to dynamically estimate thick and thin regions to improve contrast and visibility in over-penetrated and under-penetrated regions.”
AlgorithmDeep Learning Al model that provides more consistent image presentations to the user which reduces additional workflow to adjust the image display parameters. The image processing algorithm uses artificial intelligence to dynamically estimate thick and thin regions to improve contrast and visibility in over-penetrated and under-penetrated regions.
source quote (p.7)
“An update was made to the previously cleared Tissue Equalization feature under K013481 to introduce a Deep Learning Al model that provides more consistent image presentations to the user which reduces additional workflow to adjust the image display parameters. The image processing algorithm uses artificial intelligence to dynamically estimate thick and thin regions to improve contrast and visibility in over-penetrated and under-penetrated regions.”
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)
Bench
sample size not stated
Retrospective clinical
sample size not stated
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
13
recalls in product code, 24mo
42
MAUDE reports in code, 12mo
+14%
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).