InferCare RECIST
K252261Beijing Infervision Healthcare Medical Technology Co., Ltd. · cleared 2026-03-13 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“InferCare RECIST is a post-processing software application used to display, process, analyze, quantify and manipulate multi-time-point CT images.”
source quote (p.4)
“The software utilizes artificial intelligence algorithms for automated lesion segmentation and registration, and the results require confirmation by a medical professional.”
source quote (p.9)
“Cybersecurity and vulnerability analyses were conducted, and it has been determined that InferCare RECIST conforms to the cybersecurity requirements.”
Validation studies (2)
Standalone
n=212 other
endpoints: Match Rate; Centroid Error Distance
standards: IEC 62304:2006+A1:2015, ISO 14971:2019
Standalone
n=102 cases
endpoints: Segmentation accuracy; Long/Short diameter measurement
standards: IEC 62304:2006+A1:2015, ISO 14971:2019
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
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).