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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K253182

510(k) cleared

InkSpace Imaging Small Body Array (SBA12PH30x)

Inkspace Imaging, Inc. · Oct 20, 2025 · K253182

FDA cleared the InkSpace Imaging Small Body Array (SBA12PH30x) from Inkspace Imaging, Inc. on Oct 20, 2025 under K253182, 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 Sep 26, 2025. The decision came 24 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 K253182?

K253182 is the FDA 510(k) for InkSpace Imaging Small Body Array (SBA12PH30x), submitted by Inkspace Imaging, Inc.. FDA's decision date was Oct 20, 2025, under product code MOS (Coil, Magnetic Resonance, Specialty).

Who makes the InkSpace Imaging Small Body Array (SBA12PH30x)?

Inkspace Imaging, Inc., based in Pleasanton, CA, is the applicant of record for K253182.

How long did the K253182 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Oct 20, 2025, 24 days later.

← All decisions in October 2025