Sectra Digital Pathology Module (Version 3.3)
FDA 510(k)Class II (US FDA 510(k))
by Sectra AB
Identifiers
- 510(k) Number
- K232208 FDA 510(k)
- FDA Product Code
- PSY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.3700 FDA 510(k)
- Regulation Number
- 864.3700 FDA 510(k)
- Advisory Committee
- Pathology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sectra Digital Pathology Module (Version 3.3) is a software-only digital slide viewing system that functions as an add-on module to Sectra PACS (Workstation IDS7). It retrieves and displays digital pathology images in SVS and DICOM formats generated by the Leica Aperio GT 450 DX scanner. This device is classified as a Whole Slide Imaging System with product code PSY.
The device is manufactured by Sectra AB in Linköping, Sweden and received FDA 510(k) clearance on April 16, 2024 under approval number K232208. It is a Class II medical device with special controls. The module is supplied as software and is intended for use with compatible Sectra PACS systems to view digital pathology images.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sectra Digital Pathology Module (Version 3.3) (K232208) — FDA 510 (k ..., K232208 FDA 510(k) - Sectra Digital Pathology Module (Versio..., Sectra Digital Pathology Module (Version 3.3) — FDA K232208
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232208 | Class II | Active |
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Manufacturer
- Manufacturer
- Sectra AB
Sources (1)
- FDA 510(k) K232208 24 fields · synced Sep 22, 2026