FDA Clearance Expands Digital Pathology Options for Clinical Laboratories

K. (Hamamatsu, Japan) announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the NanoZoomer S20MD and NanoZoomer S540MD slide scanner systems. The clearance, dated September 2, 2026, expands the company’s FDA‑cleared NanoZoomer portfolio in the United States. The two systems build on the previously cleared NanoZoomer S360MD to give clinical pathology laboratories additional configuration choices aligned to their operations.

The FDA‑cleared NanoZoomer lineup now spans compact benchtop deployment with the S20MD, routine laboratory workflows with the S360MD, and high‑throughput laboratory operations with the S540MD. The products are designed to provide a consistent user experience across the NanoZoomer family, facilitating selection based on throughput and space constraints. The new clearances add options intended for both space‑limited benches and centralized, high‑volume sites.

By extending cleared configurations from routine to compact and high‑throughput systems, the platform increases access to FDA‑cleared digital pathology slide scanning across a broader set of laboratories. The approach enables institutions to match differing operational requirements while maintaining consistency across models. The clearances broaden the availability of FDA‑cleared NanoZoomer systems in the United States and give clinical pathology laboratories greater choice when selecting a system.

"The FDA clearances of the NanoZoomer S20MD and the NanoZoomer S540MD represent an important milestone for Hamamatsu as we continue to expand our FDA-cleared portfolio," said Scott Blakely, Business Development Manager, Americas. "These clearances reflect our commitment to providing laboratories with a range of solutions that deliver the image quality, reliability, and long-term performance that define the NanoZoomer platform."