Home › Device types › PSY
Whole Slide Imaging System
FDA product code PSY · Class 2 · Pathology
21
Registered devices
8
Adverse events
2
Recalls
23
510(k) clearances
Devices with this code
Philips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Barco — Barco NVPhilips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Philips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Concentriq AP-Dx-US — Proscia Inc.Aperio AT2 DX Scanner — LEICA BIOSYSTEMS IMAGING, INCPhilips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.BARCO — Barco NVPhilips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Synapse Pathology — Fujifilm Healthcare Americas CorporationBARCO — Barco NVConcentriq AP-Dx — Proscia Inc.Barco — Barco NVBarco — Barco NVNanoZoomer S360MD Slide scanner system — HAMAMATSU PHOTONICS K.K.Barco — Barco NVVENTANA DP 600 slide scanner — Roche Diagnostics GmbHEpredia — SHANDON DIAGNOSTICS LIMITEDConcentriq AP-Dx — Proscia Inc.Philips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V.Aperio GT 450 DX (US) Scanner — LEICA BIOSYSTEMS IMAGING, INC
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.