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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 / K260525

510(k) cleared

NextMR Spine

MRI2CT, Inc. · Sep 4, 2026 · K260525

FDA cleared the NextMR Spine from MRI2CT, Inc. on Sep 4, 2026 under K260525, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 17, 2026. The decision came 199 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 MRI2CT, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260525?

K260525 is the FDA 510(k) for NextMR Spine, submitted by MRI2CT, Inc.. FDA's decision date was Sep 4, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the NextMR Spine?

MRI2CT, Inc., based in Claymont, DE, is the applicant of record for K260525.

How long did the K260525 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Sep 4, 2026, 199 days later.

← All decisions in September 2026