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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 / July 2026 / K261471

510(k) cleared

Zeta TMS Navigation System

Zeta Surgical, Inc. · Jul 9, 2026 · K261471 · In the directory

FDA cleared the Zeta TMS Navigation System from Zeta Surgical, Inc. on Jul 9, 2026 under K261471, a special 510(k). The device falls under product code QFF, Electromechanical Arm For A Transcranial Magnetic Stimulation System, regulated at 21 CFR 882.5805 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 4, 2026. The decision came 66 days later, inside the 90 FDA-day goal for a 510(k).

Zeta Surgical, Inc. has one other decision in the tracker over the last 12 months: K253663 (Zeta Navigation System).

Questions & Answers

What did FDA clear under K261471?

K261471 is the FDA 510(k) for Zeta TMS Navigation System, submitted by Zeta Surgical, Inc.. FDA's decision date was Jul 9, 2026, under product code QFF (Electromechanical Arm For A Transcranial Magnetic Stimulation System).

Who makes the Zeta TMS Navigation System?

Zeta Surgical, Inc., based in Boston, MA, is the applicant of record for K261471. The company is listed in the MedDevice Startups directory.

How long did the K261471 review take?

FDA received the submission on May 4, 2026 and issued its decision on Jul 9, 2026, 66 days later.

← All decisions in July 2026

Sources

In the startup directory

Zeta Surgical

Surgical & Robotics · Boston, MA