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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / July 2026 / K260973

510(k) cleared

InferOperate Suite

Beijing Infervision Healthcare Medical Technology Co., Ltd. · Jul 7, 2026 · K260973

FDA cleared the InferOperate Suite from Beijing Infervision Healthcare Medical Technology Co., Ltd. on Jul 7, 2026 under K260973, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 24, 2026. The decision came 105 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beijing Infervision Healthcare Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252261 (InferCare RECIST).

Questions & Answers

What did FDA clear under K260973?

K260973 is the FDA 510(k) for InferOperate Suite, submitted by Beijing Infervision Healthcare Medical Technology Co., Ltd.. FDA's decision date was Jul 7, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the InferOperate Suite?

Beijing Infervision Healthcare Medical Technology Co., Ltd., based in Beijing, is the applicant of record for K260973.

How long did the K260973 review take?

FDA received the submission on Mar 24, 2026 and issued its decision on Jul 7, 2026, 105 days later.

← All decisions in July 2026

Sources