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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 / September 2026 / K260758

510(k) cleared

MAGNETOM Free.Max; MAGNETOM Free.Star

Siemens Shenzhen Magnetic Resonance , Ltd. · Sep 1, 2026 · K260758

FDA cleared the MAGNETOM Free.Max; MAGNETOM Free.Star from Siemens Shenzhen Magnetic Resonance , Ltd. on Sep 1, 2026 under K260758, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 9, 2026. The decision came 176 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Shenzhen Magnetic Resonance , Ltd. has 2 other decisions in the tracker over the last 12 months: K260265 (MAGNETOM Flow.Ace; MAGNETOM Flow.Plus), K251822 (MAGNETOM Free.Max; MAGNETOM Free.Star).

Questions & Answers

What did FDA clear under K260758?

K260758 is the FDA 510(k) for MAGNETOM Free.Max; MAGNETOM Free.Star, submitted by Siemens Shenzhen Magnetic Resonance , Ltd.. FDA's decision date was Sep 1, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the MAGNETOM Free.Max; MAGNETOM Free.Star?

Siemens Shenzhen Magnetic Resonance , Ltd., based in Shenzhen, is the applicant of record for K260758.

How long did the K260758 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Sep 1, 2026, 176 days later.

← All decisions in September 2026

Sources