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Epredia E1000 Dx Digital Pathology Solution
EUDAMEDFDA UDIFDA 510(k)Class A (EU MDR)
Ref A85200002
Identity
- Trade Name
- Epredia E1000 Dx Digital Pathology Solution EUDAMEDEpredia FDA UDI
- Generic Name
- Microscope slide digital imaging scanner IVD FDA UDI
- Device Name
- E1000 Dx Digital Pathology Solution EUDAMEDThe 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 firmware E1000 Dx Scanner Software Viewer component: E1000 Dx Image Management System (IMS) Server E1000 Dx Viewer Software Display component: Barco MDPC-8127 FDA UDI
- Model / Reference
- A85200002 EUDAMEDE1000 Dx Digital Pathology Solution FDA UDI
- Description
- 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 firmware E1000 Dx Scanner Software Viewer component: E1000 Dx Image Management System (IMS) Server E1000 Dx Viewer Software Display component: Barco MDPC-8127 FDA UDI
Identifiers
- Catalog Number
- A85200002 FDA UDI
- Primary DI / UDI-DI
- 05051663010467 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051663SDL025KG EUDAMED
- Direct Marketing DI
- 05051663010467 EUDAMED
- 510(k) Number
- K241717 FDA UDI
- FDA Product Code
- PZZ FDA UDIQKQ FDA UDIPSY FDA UDI
- EMDN Code
- W0202050304 DIGITAL LABORATORY MICROSCOPES EUDAMED
- GMDN Term
- Microscope slide digital imaging scanner IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.3700 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Epredia E1000 Dx Digital Pathology Solution by Shandon Diagnostics Limited — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241717 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 5051663SDL025KG | Class A | Active |
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Manufacturer
- Manufacturer
- Shandon Diagnostics Limited
- EUDAMED SRN
- GB-MF-000008187
- Authorised Representative
- Epredia Netherlands B.V. NL-AR-000001488
Sources (3)
- EUDAMED 3dff305a-2f3a-48f5-916f-7d39903fc36a 61 fields · synced Jul 29, 2026
- FDA UDI 4c5d05e9-e7e8-48f0-be01-732b8fe94d79 35 fields · synced May 29, 2026
- FDA 510(k) K241717 1 fields · synced May 18, 2026