InferCare RECIST

FDA 510(k) K252261 · Beijing Infervision Healthcare Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK252261

Submission

Device name
InferCare RECIST
Applicant
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Beijing, CN
Received
July 21, 2025
Decision date
March 13, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QIH – Automated Radiological Image Processing Software
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

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More from Lucida Medical, Ltd.

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Questions and answers

When was InferCare RECIST cleared by the FDA?

InferCare RECIST (K252261) received a 510(k) decision of Substantially Equivalent on March 13, 2026, 235 days after the submission was received.

What is the product code of K252261?

The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.