Aperio AT2 DX Scanner
- Primary DI
- 00815477020259
- Brand
- Aperio AT2 DX Scanner
- Company
- LEICA BIOSYSTEMS IMAGING, INC
- Model
- 23AT2DX
- Device description
- The Aperio AT2 DX System is composed of the Aperio AT2 DX scanner, the ImageScope DX review application and display. The Aperio AT2 DX System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using the Aperio AT2 DX System.
- Published
- 2020-01-23
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Contact Domains#
leicabiosystems.comProduct Codes#
| Code | Name |
|---|---|
| PSY | Whole slide imaging system |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PSY | Whole Slide Imaging System | Pathology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00815477020259 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00815477020259 | 00815477020259 | 815477020259 | 0815477020259 |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Contacts#
| Phone | |
|---|---|
| +1 844 534 2262 | TechServices@LeicaBiosystems.com |
Regulatory Flags#
- DUNS number
- 063440460
- 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 |
|---|---|---|---|---|
| 00815477020877 | Aperio HALO AP DX | 23HALOAPDX | 2026-10-26 | |
| 00815477020686 | Aperio GT 180 DX | 23GT180DXUS | 2026-10-22 | |
| 00815477020693 | Aperio iQC DX Software | 23iQCDXUS | 2026-10-22 | |
| 00815477020051 | eIHC IVD bundle CS2- 2500 | 23CS2IVD-2500 | 2016-09-19 | |
| 00815477020068 | eIHC IVD bundle AT Turbo-2500 | 23ATTIVD-2500 | 2016-09-19 | |
| 00815477020525 | Aperio GT 450 DX (US) Scanner | 23GT450DXUS | 2024-05-31 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00815477020686 | Aperio GT 180 DX | LEICA BIOSYSTEMS IMAGING, INC | PSY | 2026-10-22 |
| 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 |
| 04582389011267 | Agilent 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 |
| 00884838085640 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | 2017-12-15 |