Agilent S540MD Slide Scanner System
- Primary DI
- 04582389011267
- Brand
- Agilent S540MD Slide Scanner System
- Company
- HAMAMATSU PHOTONICS K.K.
- Model
- C17400-51MD
- Published
- 2026-08-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| PSY | Whole Slide Imaging System |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PSY | Whole Slide Imaging System | Pathology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K260964 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04582389011267 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04582389011267 | 04582389011267 | 4582389011267 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Regulatory Flags#
- DUNS number
- 704524537
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04582389010734 | NanoZoomer S20MD Slide scanner system | C16300-01MD | 2026-08-03 | |
| 04582389011236 | NanoZoomer S540MD Slide scanner system | C17400-01MD | 2026-08-03 | |
| 04582389010659 | NanoZoomer S360MD Slide scanner system | C13220-01MD | 2022-10-01 | |
| 04582389010871 | PDE-GEN3 | C13999-40 | 2023-06-01 | |
| 04582389010031 | PDE | C9830-40 | 2016-09-23 | |
| 04582389010062 | NIRO-200NX | C10448-20 | 2016-09-23 | |
| 04582389010093 | pde-neo | C10935-40 | 2016-09-23 | |
| 04582389010543 | pde-neoII | C10935-400 | 2016-09-23 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04582389010734 | NanoZoomer S20MD Slide scanner system | HAMAMATSU PHOTONICS K.K. | PSY | 2026-08-03 |
| 04582389011236 | NanoZoomer S540MD Slide scanner system | HAMAMATSU PHOTONICS K.K. | PSY | 2026-08-03 |
| 07613336206737 | VENTANA DP 600 slide scanner | Roche Diagnostics GmbH | PSY | 2025-12-15 |
| 00884838124325 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | 2025-09-01 |
| 00884838124349 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | 2025-09-01 |
| 00860006054595 | Concentriq AP-Dx | Proscia Inc. | PSY | 2025-05-08 |
| 05415334055919 | Barco | Barco NV | PSY | 2025-04-08 |
| 05415334055926 | Barco | Barco NV | PSY | 2025-04-08 |
| 05415334056244 | Barco | Barco NV | PSY | 2025-04-08 |
| 05415334056251 | Barco | Barco NV | PSY | 2025-04-08 |
| 05051663010467 | Epredia | SHANDON DIAGNOSTICS LIMITED | PSY | 2025-03-10 |
| 00884838121263 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | 2025-02-24 |
| 00860006054557 | Concentriq AP-Dx-US | Proscia Inc. | PSY | 2025-01-15 |
| 00884838121270 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | 2024-10-08 |
| 00860006054519 | Concentriq AP-Dx | Proscia Inc. | PSY | 2024-08-26 |
| 00884838092105 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | 2024-07-15 |
| 00815477020525 | Aperio GT 450 DX (US) Scanner | LEICA BIOSYSTEMS IMAGING, INC | PSY | 2024-05-31 |
| 05415334044289 | BARCO | Barco NV | PSY | 2023-12-19 |
| 05415334044371 | BARCO | Barco NV | PSY | 2023-12-19 |
| 00854904006039 | Synapse Pathology | Fujifilm Healthcare Americas Corporation | PSY | 2023-06-16 |
| 04582389010659 | NanoZoomer S360MD Slide scanner system | HAMAMATSU PHOTONICS K.K. | PSY | 2022-10-01 |
| 00815477020259 | Aperio AT2 DX Scanner | LEICA BIOSYSTEMS IMAGING, INC | PSY | 2020-01-23 |
| 00884838085640 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | 2017-12-15 |