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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 / June 2026 / K253786

510(k) cleared

syngo.CT Coronary Cockpit

Siemens Medical Solutions USA, Inc. · Jun 25, 2026 · K253786

FDA cleared the syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc. on Jun 25, 2026 under K253786, 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 Nov 26, 2025. The decision came 211 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Medical Solutions USA, Inc. has 8 other decisions in the tracker over the last 12 months: K260055 (syngo.CT Brain Quantification), K261696 (ACUNAV Luxera 4D ICE Catheter), K260488 (MULTIX Impact; MULTIX Impact C), K253678 (MAMMOMAT B.brilliant (11372950)).

Questions & Answers

What did FDA clear under K253786?

K253786 is the FDA 510(k) for syngo.CT Coronary Cockpit, submitted by Siemens Medical Solutions USA, Inc.. FDA's decision date was Jun 25, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the syngo.CT Coronary Cockpit?

Siemens Medical Solutions USA, Inc., based in Knoxville, TN, is the applicant of record for K253786.

How long did the K253786 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Jun 25, 2026, 211 days later.

← All decisions in June 2026