InferCare RECIST
K-Number: K252261 · 2026-03-13
Decision Date2026-03-13
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
InferCare RECIST is a medical device manufactured by Beijing Infervision Healthcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-13 under approval number K252261. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the InferCare RECIST?
InferCare RECIST is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by Beijing Infervision Healthcare Medical Technology Co., Ltd.. The 510(k) number is K252261.
When was InferCare RECIST approved by the FDA?
InferCare RECIST received FDA 510(k) clearance on 2026-03-13, under approval number K252261.
What company makes InferCare RECIST?
InferCare RECIST is manufactured by Beijing Infervision Healthcare Medical Technology Co., Ltd..
What is the FDA product code for InferCare RECIST?
The FDA product code for InferCare RECIST is QIH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.