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FDA 510(k)

Sectra Digital Pathology Module (Version 3.3)

K-Number: K232208 · 2024-04-16

ApplicantSectra AB
Decision Date2024-04-16
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Sectra Digital Pathology Module (Version 3.3) is a medical device manufactured by Sectra AB. It received FDA 510(k) clearance on 2024-04-16 under approval number K232208. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sectra Digital Pathology Module (Version 3.3)?

Sectra Digital Pathology Module (Version 3.3) is a medical device that received FDA 510(k) clearance on 2024-04-16. It is manufactured by Sectra AB. The 510(k) number is K232208.

When was Sectra Digital Pathology Module (Version 3.3) approved by the FDA?

Sectra Digital Pathology Module (Version 3.3) received FDA 510(k) clearance on 2024-04-16, under approval number K232208.

What company makes Sectra Digital Pathology Module (Version 3.3)?

Sectra Digital Pathology Module (Version 3.3) is manufactured by Sectra AB.

What is the FDA product code for Sectra Digital Pathology Module (Version 3.3)?

The FDA product code for Sectra Digital Pathology Module (Version 3.3) is PSY.

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Related PubMed Literature

PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021) PMID: 28584684 Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA. Journal of pathology informatics (2017)

Other Devices by Sectra AB

K193054Sectra Digital Pathology Module

Related Devices (Code: PSY)

K172174Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. DEN160056Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. K192259Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V. K190332Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. K203845Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. K203364MDPC-8127Barco N.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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