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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Two More Hamamatsu NanoZoomer Slide Scanners for Clinical Pathology

The benchtop S20MD and high-throughput S540MD join the S360MD as whole slide imaging systems cleared for reviewing digital pathology slides.

By News DeskSeptember 2, 20262 min read
A cardboard case holding a row of old glass microscope slides with paper labels
A set of glass microscope specimen slides made in Germany around 1914, held by the Missouri History Museum. Not related to Hamamatsu or its scanners. Missouri History Museum, Public domain, via Wikimedia Commons · Public domain
FDA cleared510(k) · K260964FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA found Hamamatsu's NanoZoomer S20MD (K253606, July 15) and NanoZoomer S540MD (K260964, July 22) substantially equivalent; the company announced them on September 2, 2026.
  • Both are whole slide imaging systems, which the FDA classes as aids for pathologists reviewing digital images of paraffin-embedded surgical pathology slides.
  • The classification excludes frozen tissue, cytology and blood smears, and does not cover automated image analysis.

Hamamatsu Photonics said on September 2 that the US Food and Drug Administration has cleared two more of its NanoZoomer digital slide scanners for clinical pathology, the compact benchtop NanoZoomer S20MD and the high-throughput NanoZoomer S540MD, in a release distributed by PR Newswire. The Japanese company's NanoZoomer S360MD, for routine laboratory work, was already cleared.

The FDA's 510(k) database shows two decisions. Submission K253606, covering the NanoZoomer S20MD and NanoZoomer S360MD slide scanner systems, was received on November 18, 2025, and found substantially equivalent on July 15, 2026. Submission K260964, for the NanoZoomer S540MD Slide Scanner System, was received on March 23, 2026, and found substantially equivalent on July 22, 2026. Both are listed under regulation 864.3700 with product code PSY.

What a whole slide imaging system is

The FDA's classification entry for product code PSY describes a whole slide imaging system as an automated system for creating, viewing and managing digital slides, intended as an aid to the pathologist in reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded tissue. The system produces images that would otherwise be suitable for viewing under a conventional brightfield microscope.

The classification is limited. According to the FDA entry, these systems are not intended for slides prepared from frozen tissue, cytology or non-paraffin hematopathology specimens such as peripheral blood smears. A whole slide imaging system consists of an image management system, a scanner and its software, and a display monitor, and does not include automated image analysis applications that would amount to computer-aided detection or diagnosis. Pathologists view and interpret the scanned images.

A three-model lineup

With the two new clearances, Hamamatsu said, its FDA-cleared NanoZoomer portfolio now spans three settings: the S20MD for compact benchtop deployment, the S360MD for routine laboratory workflows and the S540MD for high-throughput laboratory operations. The company said the systems provide a consistent user experience across the product family and give clinical pathology laboratories more choice in matching a scanner to their workload.

"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, the company's business development manager for the Americas.

Hamamatsu said its NanoZoomer series has been used for whole slide imaging in pathology research for more than two decades. The release did not give US pricing, shipping dates or the names of any laboratory customers for the newly cleared models.

Sources

  1. Hamamatsu Receives FDA 510(k) Clearance for NanoZoomer S20MD and S540MD Slide scanner systems, Hamamatsu Photonics (PR Newswire), September 2, 2026
  2. 510(k) Premarket Notification K253606: NanoZoomer S20MD and S360MD Slide scanner systems, US Food and Drug Administration, July 15, 2026
  3. 510(k) Premarket Notification K260964: NanoZoomer S540MD Slide Scanner System, US Food and Drug Administration, July 22, 2026
  4. Product Classification: whole slide imaging system (PSY), US Food and Drug Administration