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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 / October 2026 / K262813

510(k) cleared

InkSpace Imaging Small Body Array (SBA12PH15x)

Inkspace Imaging, Inc. · Oct 5, 2026 · K262813

FDA cleared the InkSpace Imaging Small Body Array (SBA12PH15x) from Inkspace Imaging, Inc. on Oct 5, 2026 under K262813, a special 510(k). The device falls under product code MOS, Coil, Magnetic Resonance, Specialty, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 7, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Inkspace Imaging, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262813?

K262813 is the FDA 510(k) for InkSpace Imaging Small Body Array (SBA12PH15x), submitted by Inkspace Imaging, Inc.. FDA's decision date was Oct 5, 2026, under product code MOS (Coil, Magnetic Resonance, Specialty).

Who makes the InkSpace Imaging Small Body Array (SBA12PH15x)?

Inkspace Imaging, Inc., based in Pleasanton, CA, is the applicant of record for K262813.

How long did the K262813 review take?

FDA received the submission on Aug 7, 2026 and issued its decision on Oct 5, 2026, 59 days later.

← All decisions in October 2026