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FDA-cleared K252261

InferCare RECIST

Beijing Infervision Healthcare Medical Technology Co., Ltd.

Authorized purpose: InferCare RECIST is a post-processing application for longitudinal medical-image display, lesion measurement, registration, tracking, segmentation, three-dimensional reconstruction, and RECIST reporting by trained professionals.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Tumors and lesions in adult patients age 21 and older
Decision
2026-03-13
FDA-cleared K250237

InferOperate Suite

Beijing Infervision Healthcare Medical Technology Co., Ltd.

Authorized purpose: InferOperate Suite supports trained healthcare professionals in reading, interpreting, reporting, and treatment planning from medical images, with the submission's machine-learning functions applied to adult chest, abdomen, and pelvis CT.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Chest; abdomen; pelvis; and general patient anatomy represented in supported images
Decision
2025-09-15