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Beijing Infervision Healthcare Medical Technology Co., Ltd.: FDA-registered device maker in Beijing, China, 6 510(k) clearances

Name: Beijing Infervision Healthcare Medical Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Beijing Infervision Healthcare Medical Technology Co., Ltd. is registered with the FDA (registration 3017489096) in Beijing, China. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 7, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3017489096
Address: Room 401, 4th Floor, Building 1, No.12, Shangdi Information Road, Haidian District, Beijing, China, Beijing, China, 100085
Owner or operator: Infervision US Inc (10079796)
Roles: Complaint file establishment, Manufacturer
First device listed: December 23, 2020
Registered through: 2026
Brand names listed: InferCare RECIST, InferOperate Suite, InferRead CT Lung, InferRead CT Stroke.AI, InferRead Lung CT.AI

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lung Computed Tomography System, Computer-Aided Detection	OEB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Triage And Notification Software	QAS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 7, 2026	K260973	InferOperate Suite	QIH	Substantially Equivalent	Beijing Infervision Healthcare Medical Technology Co., Ltd.	accessdata.fda.gov
March 13, 2026	K252261	InferCare RECIST	QIH	Substantially Equivalent	Beijing Infervision Healthcare Medical Technology Co., Ltd.	accessdata.fda.gov
September 15, 2025	K250237	InferOperate Suite	QIH	Substantially Equivalent	Beijing Infervision Healthcare Medical Technology Co., Ltd.	accessdata.fda.gov
May 16, 2025	K240554	InferRead Lung CT.AI	OEB	Substantially Equivalent	Infervision Medical Technology Co., Ltd.	accessdata.fda.gov
August 12, 2021	K211179	InferRead CT Stroke.AI	QAS	Substantially Equivalent	Infervision Medical Technology Co., Ltd.	accessdata.fda.gov
July 2, 2020	K192880	InferRead Lung CT.AI	OEB	Substantially Equivalent	Beijing Infervision Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.