E1000 Dx Digital Pathology Solution
Shandon Diagnostics Limited
SHANDON DIAGNOSTICS LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003584784 | 3003584784 | SHANDON DIAGNOSTICS LIMITED | 1 | N | 2027-01-01 | TUDOR ROAD MANOR PARK RUNCORN Cheshire East GB WA7 1TA |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 239739 | 1753619478 | K241717 | E1000 Dx Digital Pathology Solution | PSY | 2025-02-28 |
| 239739 | 1029100275 | ||||
| 239739 | 1148076654 | ||||
| 239739 | 1302226974 | ||||
| 239739 | 1319833080 | ||||
| 239739 | 1409499150 | ||||
| 239739 | 1458648923 | ||||
| 239739 | 1648910288 | ||||
| 239739 | 1663803211 | ||||
| 239739 | 1692774702 | ||||
| 239739 | 1741348039 | ||||
| 239739 | 1899488386 | ||||
| 239739 | 1932378673 | ||||
| 239739 | 1830311306 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PSY | 1 | 2025-02-28 |
PMN#
GUDID#
Epredia - Stripped stacks, 25x40mm
2026-03-11
Epredia - Stripped stacks, 25x40mm
2026-03-11
Epredia - Cryostat
2025-11-07
Epredia - Cryostat
2025-11-07
Epredia - HM525 NX Cryostat-UK
2025-08-26
Epredia - HM525 NX UV Cryostat-UK
2025-08-26
Epredia - Rotary Microtome
2025-06-11
Epredia - The E1000 Dx Digital Pathology Solution is a high-capacity, automated whole slide imaging system for the creation, viewing, and management of digital images of surgical pathology slides. It allows whole slide digital images to be viewed on a display monitor that would otherwise be appropriate for manual visualization by conventional brightfield microscopy.The E1000 Dx Digital Pathology Solution consists of the following three components:Scanner component:E1000 Dx Digital Pathology Scanner with E1000 firmwareE1000 Dx Scanner SoftwareViewer component:E1000 Dx Image Management System (IMS) ServerE1000 Dx Viewer SoftwareDisplay component:Barco MDPC-8127
2025-03-10
Epredia - Revos IVD Accessory
2024-06-13
Epredia - Revos Tissue Processor IVD Accessory
2024-06-13
Epredia - Revos Tissue Processor IVD Accessory
2024-06-13
Epredia - Rotary Microtome
2024-05-10
Epredia - Rotary Microtome
2024-05-10
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - ClearVue coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16
Epredia - CTM6 coverslipper- Accessory
2024-02-16