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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 / February 2026 / K254016

510(k) cleared

MI View&GO

Siemens Medical Solutions USA, Inc. · Feb 10, 2026 · K254016

FDA cleared the MI View&GO from Siemens Medical Solutions USA, Inc. on Feb 10, 2026 under K254016, a special 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 Dec 15, 2025. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

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), K253786 (syngo.CT Coronary Cockpit).

Questions & Answers

What did FDA clear under K254016?

K254016 is the FDA 510(k) for MI View&GO, submitted by Siemens Medical Solutions USA, Inc.. FDA's decision date was Feb 10, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the MI View&GO?

Siemens Medical Solutions USA, Inc., based in Hoffman Estates, IL, is the applicant of record for K254016.

How long did the K254016 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Feb 10, 2026, 57 days later.

← All decisions in February 2026