WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / February 2026 / K253780

510(k) cleared

SIGNA Bolt

Ge Medical Systems, LLC · Feb 6, 2026 · K253780

FDA cleared the SIGNA Bolt from Ge Medical Systems, LLC on Feb 6, 2026 under K253780, 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 Nov 26, 2025. The decision came 72 days later, inside the 90 FDA-day goal for a 510(k).

Ge Medical Systems, LLC has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K253780?

K253780 is the FDA 510(k) for SIGNA Bolt, submitted by Ge Medical Systems, LLC. FDA's decision date was Feb 6, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the SIGNA Bolt?

Ge Medical Systems, LLC, based in Waukesha, WI, is the applicant of record for K253780.

How long did the K253780 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Feb 6, 2026, 72 days later.

← All decisions in February 2026