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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 / October 2025 / K251030

510(k) cleared

Sirona Advanced Imaging Suite

Sirona Medical · Oct 22, 2025 · K251030 · In the directory

FDA cleared the Sirona Advanced Imaging Suite from Sirona Medical on Oct 22, 2025 under K251030, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 3, 2025. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Sirona Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251030?

K251030 is the FDA 510(k) for Sirona Advanced Imaging Suite, submitted by Sirona Medical. FDA's decision date was Oct 22, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the Sirona Advanced Imaging Suite?

Sirona Medical, based in San Francisco, CA, is the applicant of record for K251030. The company is listed in the MedDevice Startups directory.

How long did the K251030 review take?

FDA received the submission on Apr 3, 2025 and issued its decision on Oct 22, 2025, 202 days later.

← All decisions in October 2025

Sources

In the startup directory

Sirona Medical

Imaging & Radiology · San Francisco, CA