# K252261: InferCare RECIST

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Infervision Healthcare Medical Technology Co., Ltd.
- Decided: Mar 13, 2026 after 235 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162955: Multi-Modality Tumor Tracking (MMTT) application, Philips Medical Systems Nederland B.V. (2016) Summary page 5.

## Indications for use
InferCare RECIST is a post-processing software application used to display, process, analyze, quantify and manipulate multi-time-point CT images. It is intended to be used by trained medical professionals in evaluating and managing tumors in various organs, tissues, and other anatomical structures based on RECIST criteria. InferCare RECIST offers functionalities for lesion measurement, registration, tracking, and RECIST report. It provides tools for interactive segmentation, and 3D reconstruction visualization. The software utilizes artificial intelligence algorithms for automated lesion segmentation and registration, and the results require confirmation by a medical professional. The software's artificial intelligence algorithms are intended for patients aged 21 years and older.

Source page: https://510kreport.com/device/K252261
Methodology: https://510kreport.com/methodology