Hamamatsu receives FDA 510(k) clearance for NanoZoomer S20MD and S540MD slide scanner systems

2026/09/02
  • Hamamatsu Corporation

New FDA clearances expand Hamamatsu's FDA-cleared NanoZoomer portfolio with compact benchtop and high-throughput digital pathology solutions.

 

Hamamatsu Photonics K.K. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the NanoZoomer S20MD and NanoZoomer S540MD Slide scanner systems. Building on the previously cleared NanoZoomer S360MD, these additions broaden the availability of FDA-cleared NanoZoomer systems in the United States, giving clinical pathology laboratories greater choice when selecting a NanoZoomer system that aligns with their operational requirements.

 

With FDA-cleared systems spanning compact, routine, and high-throughput laboratory operations, Hamamatsu now offers a comprehensive NanoZoomer platform that provides a consistent user experience across the NanoZoomer product family.

 

The FDA-cleared NanoZoomer portfolio now includes:

 

  • NanoZoomer S20MD - Compact benchtop deployment
  • NanoZoomer S360MD - Routine laboratory workflows
  • NanoZoomer S540MD - High-throughput laboratory operations