InferCare RECIST— 510(k) K252261
Substantially EquivalentBeijing Infervision Healthcare Medical Technology Co., Ltd.
FDA 510(k) clearance K252261 for InferCare RECIST, Substantially Equivalent on 2026-03-13. Applicant: Beijing Infervision Healthcare Medical Technology Co., Ltd.. Device class: 2.
Summary
Beijing Infervision Healthcare Medical Technology's InferCare RECIST is filed under QIH, automated radiological image processing software. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. It was a Traditional 510(k), and Radiology is both the classification panel and the review panel.
Beijing Infervision Healthcare Medical Technology filed from Beijing, China. The decision came 235 calendar days after FDA received it (July 21, 2025 to March 13, 2026).
Clearance details
- Applicant
- Beijing Infervision Healthcare Medical Technology Co., Ltd.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code QIH
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