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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K260227

510(k) cleared

EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H

DRTECH Corporation · Sep 8, 2026 · K260227

FDA cleared the EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H from DRTECH Corporation on Sep 8, 2026 under K260227, a traditional 510(k). The device falls under product code KPR, System, X-Ray, Stationary, regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 26, 2026. The decision came 225 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: K261413 (EXTRON 3;EXTRON 6).

Questions & Answers

What did FDA clear under K260227?

K260227 is the FDA 510(k) for EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H, submitted by DRTECH Corporation. FDA's decision date was Sep 8, 2026, under product code KPR (System, X-Ray, Stationary).

Who makes the EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H?

DRTECH Corporation, based in Seongnam-Si, is the applicant of record for K260227.

How long did the K260227 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Sep 8, 2026, 225 days later.

← All decisions in September 2026

Sources