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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 / April 2026 / K253582

510(k) cleared

Medical Imaging Calibration Feature (MICF)

Apple, Inc. · Apr 1, 2026 · K253582

FDA cleared the Medical Imaging Calibration Feature (MICF) from Apple, Inc. on Apr 1, 2026 under K253582, a traditional 510(k). The device falls under product code SHN, Calibration Software For Radiology Displays, regulated at 21 CFR 892.1940 as a Class 1 device. The review panel was Radiology.

FDA logged the submission as received on Nov 17, 2025. The decision came 135 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Apple, Inc. has one other decision in the tracker over the last 12 months: K250507 (Hypertension Notification Feature (HTNF)).

Questions & Answers

What did FDA clear under K253582?

K253582 is the FDA 510(k) for Medical Imaging Calibration Feature (MICF), submitted by Apple, Inc.. FDA's decision date was Apr 1, 2026, under product code SHN (Calibration Software For Radiology Displays).

Who makes the Medical Imaging Calibration Feature (MICF)?

Apple, Inc., based in Cupertino, CA, is the applicant of record for K253582.

How long did the K253582 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Apr 1, 2026, 135 days later.

← All decisions in April 2026

Sources