Hamamatsu Photonics has received 510(k) approval from the US Food and Drug Administration (FDA) for its NanoZoomer S20MD and NanoZoomer S540MD slide scanner systems.
The clearance, which adds to the previously authorised NanoZoomer S360MD, increases the number of FDA-cleared NanoZoomer systems available for clinical pathology laboratories in the US.
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FDA-cleared NanoZoomer products include the S20MD for compact benchtop use, the S360MD for routine laboratory workflows, and the S540MD for high-throughput operations.
Hamamatsu states that this expanded range offers laboratories the opportunity to select a system that best matches their operational needs, with all devices providing a consistent user experience.
Hamamatsu America business development manager Scott Blakely said: “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.
“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.”
The NanoZoomer S20MD is a compact, scalable scanner for in vitro diagnostic use in hospitals and clinical laboratories. Designed to fit on standard lab benches, it enables whole-slide imaging for diagnostic applications.
The NanoZoomer S540MD, also designed for in vitro diagnostic use in similar settings, is aimed at laboratories that require higher throughput.
It is compatible with stainer racks, supports fast slide scanning, and accommodates both 30-slide and 20-slide setups, with rack options tailored to user needs.
Hamamatsu Photonics is involved in the design and manufacture of various photonics devices, including sensors, cameras, and measurement systems.
The company has produced the NanoZoomer series of digital scanners for more than 20 years, offering solutions for whole slide imaging in pathology research.
In September 2024, Hamamatsu Photonics launched the Cytoqube Light-Sheet Microplate Cytometer, an instrument designed for 3D cell screening assays.
