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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 / June 2026 / K252996

510(k) cleared

Universal 1417PI

Konica Minolta Healthcare Americas, Inc. · Jun 12, 2026 · K252996

FDA cleared the Universal 1417PI from Konica Minolta Healthcare Americas, Inc. on Jun 12, 2026 under K252996, a abbreviated 510(k). The device falls under product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager), regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 18, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Konica Minolta Healthcare Americas, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252996?

K252996 is the FDA 510(k) for Universal 1417PI, submitted by Konica Minolta Healthcare Americas, Inc.. FDA's decision date was Jun 12, 2026, under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Who makes the Universal 1417PI?

Konica Minolta Healthcare Americas, Inc., based in Garner, NC, is the applicant of record for K252996.

How long did the K252996 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Jun 12, 2026, 267 days later.

← All decisions in June 2026