OptraSCAN to Unveil the FDA-Cleared OS-Ultra Scanner at Pathology Visions 2026

The whole slide scanner will make its first public appearance at booth 417, following its clearance. Available starting in December.

SAN JOSE, CA, UNITED STATES, October 13, 2026 /EINPresswire.com/ -- SAN JOSE, Calif., Oct. 13, 2026 — OptraSCAN, Inc. today announced it will unveil the FDA-cleared OS-Ultra whole slide scanner at the Digital Pathology Association’s Pathology Visions 2026 conference, Oct. 16–18 in San Diego. The OS-Ultra is the scanner at the core of the OptraSCAN System, which received FDA 510(k) clearance (K260755) in July for HER2 image analysis of formalin-fixed, paraffin-embedded (FFPE) breast tissue stained with the Dako HercepTest™. Pathology Visions will mark the system’s first public showing since clearance. The FDA-cleared OS-Ultra will be available starting in December.

“FDA clearance was never the finish line. Getting a cleared system into the labs that need it was,” said Abhi Gholap, Founder & Chairman, OptraSCAN. “Plenty of laboratories have held off on digital pathology because the capital outlay or the regulatory uncertainty didn’t pencil out. We’ve removed both. A cleared system, with the OS-Ultra at its core. A pay-per-use path to it. No reason left to wait.”

The OS-Ultra is OptraSCAN’s highest-throughput scanner. It captures a 15 mm by 15 mm tissue area at 40x in under 60 seconds and holds between 80 and 480 slides depending on configuration. Continuous loading lets histotechnologists add racks without stopping a run, so the scanner works through a day’s volume while staff focus elsewhere. Images are delivered in open, standards-based formats, including DICOM, so they move freely into the image management systems, viewers, and AI tools laboratories choose, whether from OptraSCAN or other vendors.

The clearance is OptraSCAN’s first from the FDA and the defining milestone of the company’s year. It moves OptraSCAN from a scanner provider to a provider of a regulatory-reviewed digital pathology system, with the OS-Ultra as its foundation. OptraSCAN’s systems are installed at more than 165 sites in over 30 countries.

The FDA-cleared OS-Ultra will be available starting in December, through direct purchase or OptraSCAN’s pay-per-use model, which allows laboratories to begin scanning without a large upfront capital investment. Existing OS-Ultra installations remain fully supported.

Pathology Visions 2026 takes place Oct. 16–18 in San Diego. Attendees can see the OS-Ultra in person at OptraSCAN booth 417. To learn more or request a demonstration, visit https://www.optrascan.com/request-a-demo or contact info@optrascan.com.

About OptraSCAN

Headquartered in San Jose, California, OptraSCAN is a leader in digital pathology, with 165+ global installations across hospitals, reference laboratories, research institutions, and life sciences organizations in 30+ countries. Dedicated to making digital pathology accessible, affordable and scalable, OptraSCAN delivers end-to-end solutions that enable laboratories of all sizes to move from conventional microscopy to fully digital workflows through flexible deployment models, including a pay-per-use offering. Learn more at www.optrascan.com.

Media Contact

Blake Johnson, Global Marketing Director, OptraSCAN, Inc.

+1 408-524-5300 | blake@optraventures.com

Blake Johnson
OptraSCAN
+1 408-524-5300
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