InferCare RECIST

K252261

Beijing Infervision Healthcare Medical Technology Co., Ltd. · cleared 2026-03-13 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
Algorithmartificial intelligence algorithms
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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
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)

Retrospective clinical

n=86 scans

endpoints: Match Rate; Centroid Error Distance

standards: IEC 62304:2006+A1:2015, ISO 14971:2019

Retrospective clinical

n=102 cases

endpoints: Segmentation accuracy; Long/Short diameter measurement

standards: IEC 62304:2006+A1:2015, ISO 14971:2019

Reported performance (4 observations)

accuracyas written: “Segmentation Accuracy (Mean Dice) - Lung nodule”0.913CI 0.895-0.932
source quote (p.9)
“Lung nodule 42 0.913 0.895-0.932”
accuracyas written: “Segmentation Accuracy (Mean Dice) - Liver lesion”0.929CI 0.913-0.944
source quote (p.9)
“Liver lesion 23 0.929 0.913-0.944”
accuracyas written: “Segmentation Accuracy (Mean Dice) - Kidney lesion”0.904CI 0.889-0.918
source quote (p.9)
“Kidney lesion 23 0.904 0.889-0.918”
accuracyas written: “Segmentation Accuracy (Mean Dice) - Lymph node”0.782CI 0.750-0.814
source quote (p.9)
“Lymph node 14 0.782 0.750-0.814”

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); 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/K252261