InferOperate Suite
K250237Beijing Infervision Healthcare Medical Technology Co., Ltd. · cleared 2025-09-15 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“InferOperate Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients, including both preoperative surgical planning and intraoperative image display. InferOperate Suite accepts DICOM compliant medical images acquired from a variety of imaging devices. InferOperate Suite utilizes machine learning-based algorithms for adult patients undergoing CT chest, abdominal, or pelvic scans.”
source quote (p.6)
“The processing may include the generation of preliminary segmentations of anatomy using software that employs machine learning and other computer vision algorithms, as well as interactive segmentation tools, etc.”
source quote (p.12)
“In accordance with the PCCP, the modified algorithms will be adequately trained, tuned, tested, and locked before release.”
source quote (p.2)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act.”
source quote (p.10)
“Additionally, the software validation activities were performed in accordance with IEC 62304 - Medical device software – Software life cycle processes, in addition to the FDA Guidance documents, "Content of Premarket Submissions for Device Software Functions” and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." ... • Cybersecurity Testing and Analysis”
Validation studies (1)
Retrospective clinical
n=188 cases
endpoints: Dice coefficient (DSC); 95% Hausdorff Distance (HD95) (mm)
standards: IEC 62304 - Medical device software – Software life cycle processes, FDA Guidance documents, "Content of Premarket Submissions for Device Software Functions”, FDA Guidance documents, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
Reported performance (1 observation)
source quote (p.10)
“Bronchus 70 0.87 0.85-0.88 0.79 2.33 2.07-2.59 3.5”
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).