InferOperate Suite— 510(k) K250237

Name: FDA 510(k) clearance K250237
Creator: U.S. Food and Drug Administration
Published: 2025-09-15

Substantially Equivalent

Beijing Infervision Healthcare Medical Technology Co., Ltd.

FDA 510(k) clearance K250237 for InferOperate Suite, Substantially Equivalent on 2025-09-15. Applicant: Beijing Infervision Healthcare Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beijing Infervision Healthcare Medical Technology Co., Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-01-27
Decision date: 2025-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

view all

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Beijing Infervision Healthcare Medical Technology Co., Ltd.

view all

K260973 — InferOperate Suite2026-07-07
K252261 — InferCare RECIST2026-03-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.