Epredia
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Basic Information
- Brand Name
- Epredia
- Primary DI
- 05051663010467
- Version / Model
- E1000 Dx Digital Pathology Solution
- Catalog Number
- A85200002
- Company Name
- SHANDON DIAGNOSTICS LIMITED
- Labeler DUNS
- 219103512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-10
- Public Version
- 1
- Public Version Date
- 2025-03-18
- Public Version Status
- New
- Public Device Record Key
- 4c5d05e9-e7e8-48f0-be01-732b8fe94d79
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PZZ | Digital Pathology Display | Pathology | 864.3700 | 2 |
| QKQ | Digital Pathology Image Viewing And Management Software | Pathology | 864.3700 | 2 |
| PSY | Whole Slide Imaging System | Pathology | 864.3700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62575 | Microscope slide digital imaging scanner IVD | A mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051663010467 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241717 | 000 |