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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 / August 2026 / K253554

510(k) cleared

Aperio GT 450 DX; Aperio GT 180 DX

Leica Biosystems Imaging, Inc. · Aug 7, 2026 · K253554

FDA cleared the Aperio GT 450 DX; Aperio GT 180 DX from Leica Biosystems Imaging, Inc. on Aug 7, 2026 under K253554, a traditional 510(k). The device falls under product code PSY, Whole Slide Imaging System, regulated at 21 CFR 864.3700 as a Class 2 device. The review panel was Pathology.

FDA logged the submission as received on Nov 14, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Leica Biosystems Imaging, Inc. has one other decision in the tracker over the last 12 months: K253561 (Aperio iQC DX Software).

Questions & Answers

What did FDA clear under K253554?

K253554 is the FDA 510(k) for Aperio GT 450 DX; Aperio GT 180 DX, submitted by Leica Biosystems Imaging, Inc.. FDA's decision date was Aug 7, 2026, under product code PSY (Whole Slide Imaging System).

Who makes the Aperio GT 450 DX; Aperio GT 180 DX?

Leica Biosystems Imaging, Inc., based in Vista, CA, is the applicant of record for K253554.

How long did the K253554 review take?

FDA received the submission on Nov 14, 2025 and issued its decision on Aug 7, 2026, 266 days later.

← All decisions in August 2026

Sources