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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 the device name listed in this FDA 510(k) record. The listed applicant is Sectra AB. It received FDA 510(k) clearance on 2024-04-16 under 510(k) 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. The listed applicant is Sectra AB. The 510(k) number is K232208.

When did Sectra Digital Pathology Module (Version 3.3) receive FDA 510(k) clearance?

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

Who is the listed applicant for Sectra Digital Pathology Module (Version 3.3)?

The FDA 510(k) record lists Sectra AB as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Sectra AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193054Sectra Digital Pathology Module

Related Devices (Code: PSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc.K260964NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K.K251952VirasightVirasoft CorporationK253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.K243871Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.K241717E1000 Dx Digital Pathology SolutionShandon Diagnostics Limited

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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