InferOperate Suite— 510(k) K260973
Substantially EquivalentBeijing Infervision Healthcare Medical Technology Co., Ltd.
FDA 510(k) clearance K260973 for InferOperate Suite, Substantially Equivalent on 2026-07-07. Applicant: Beijing Infervision Healthcare Medical Technology Co., Ltd.. Device class: 2.
Summary
Beijing Infervision Healthcare Medical Technology's InferOperate Suite is filed under QIH, automated radiological image processing software. The record doesn't say what the suite includes or outputs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Infervision filed from Beijing, China. Review took 105 calendar days (March 24 to July 7, 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
view allMore clearances from Beijing Infervision Healthcare Medical Technology Co., Ltd.
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