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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / August 2026 / K261718

510(k) cleared

EZFluence (RADEZ V2)

Radformation, Inc. · Aug 31, 2026 · K261718

FDA cleared the EZFluence (RADEZ V2) from Radformation, Inc. on Aug 31, 2026 under K261718, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 26, 2026. The decision came 97 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Radformation, Inc. has 5 other decisions in the tracker over the last 12 months: K262452 (AutoContour (RADAC V6)), K253962 (ClearCheck (RADCC V2.7)), K260509 (AutoContour (RADAC V5)), K252988 (ChartCheck (RADCH V1.6)).

Questions & Answers

What did FDA clear under K261718?

K261718 is the FDA 510(k) for EZFluence (RADEZ V2), submitted by Radformation, Inc.. FDA's decision date was Aug 31, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the EZFluence (RADEZ V2)?

Radformation, Inc., based in New York, NY, is the applicant of record for K261718.

How long did the K261718 review take?

FDA received the submission on May 26, 2026 and issued its decision on Aug 31, 2026, 97 days later.

← All decisions in August 2026

Sources