Home › Device types › PSY
Whole Slide Imaging System
FDA product code PSY · Class 2 · Pathology
20
Registered devices
8
Adverse events
2
Recalls
23
510(k) clearances
Devices with this code
Aperio GT 450 DX (US) Scanner — LEICA BIOSYSTEMS IMAGING, INCPhilips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Aperio AT2 DX Scanner — LEICA BIOSYSTEMS IMAGING, INCPhilips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Barco — Barco NVConcentriq AP-Dx — Proscia Inc.BARCO — Barco NVVENTANA DP 600 slide scanner — Roche Diagnostics GmbHPhilips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Philips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Epredia — SHANDON DIAGNOSTICS LIMITEDBarco — Barco NVNanoZoomer S360MD Slide scanner system — HAMAMATSU PHOTONICS K.K.Synapse Pathology — Fujifilm Healthcare Americas CorporationPhilips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Barco — Barco NVPhilips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.BARCO — Barco NVConcentriq AP-Dx-US — Proscia Inc.Barco — Barco NV
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-20 | Ventana Medical Systems, Inc. | Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window |
| 2023-06-06 | Hamamatsu Corporation | If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient. |
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