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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 / August 2026 / K261413

510(k) cleared

EXTRON 3;EXTRON 6

DRTECH Corporation · Aug 19, 2026 · K261413

FDA cleared the EXTRON 3;EXTRON 6 from DRTECH Corporation on Aug 19, 2026 under K261413, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 30, 2026. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

DRTECH Corporation has one other decision in the tracker over the last 12 months: K260227 (EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H).

Questions & Answers

What did FDA clear under K261413?

K261413 is the FDA 510(k) for EXTRON 3;EXTRON 6, submitted by DRTECH Corporation. FDA's decision date was Aug 19, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the EXTRON 3;EXTRON 6?

DRTECH Corporation, based in Seongnam-Si, is the applicant of record for K261413.

How long did the K261413 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Aug 19, 2026, 111 days later.

← All decisions in August 2026

Sources