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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 / July 2026 / K260964

510(k) cleared

NanoZoomer S540MD Slide Scanner System

Hamamatsu Photonics K.K. · Jul 22, 2026 · K260964

FDA cleared the NanoZoomer S540MD Slide Scanner System from Hamamatsu Photonics K.K. on Jul 22, 2026 under K260964, a abbreviated 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 Mar 23, 2026. The decision came 121 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hamamatsu Photonics K.K. has one other decision in the tracker over the last 12 months: K253606 (NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system).

Questions & Answers

What did FDA clear under K260964?

K260964 is the FDA 510(k) for NanoZoomer S540MD Slide Scanner System, submitted by Hamamatsu Photonics K.K.. FDA's decision date was Jul 22, 2026, under product code PSY (Whole Slide Imaging System).

Who makes the NanoZoomer S540MD Slide Scanner System?

Hamamatsu Photonics K.K., based in Hamamatsu City, is the applicant of record for K260964.

How long did the K260964 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on Jul 22, 2026, 121 days later.

← All decisions in July 2026

Sources