| Primary Device ID | 00815477020525 |
| NIH Device Record Key | a9a6217c-ef4c-4359-8f76-4bc77fff1c55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aperio GT 450 DX (US) Scanner |
| Version Model Number | 23GT450DXUS |
| Company DUNS | 063440460 |
| Company Name | LEICA BIOSYSTEMS IMAGING, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00815477020525 - Aperio GT 450 DX (US) Scanner | 2024-06-10Aperio GT 450 DX Digital Pathology Scanner is a continuous slide loading while scanning, automated image quality check and Leica universal rack compatibility. Includes 15 Leica universal racks. The Aperio GT 450 DX scanner is an automated digital slide creation instrument. The Aperio GT450 DX scanner is intended for in vitro diagnostic use as an aid to the pathologist to create digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. |
| 00815477020525 - Aperio GT 450 DX (US) Scanner | 2024-06-10 Aperio GT 450 DX Digital Pathology Scanner is a continuous slide loading while scanning, automated image quality check and Leica |
| 00815477020259 - Aperio AT2 DX Scanner | 2020-01-31 Aperio AT2 DX Scanner for Primary Diagnosis. Includes installation and one day of training. One year warranty. Must be used in c |
| 00815477020051 - eIHC IVD bundle CS2- 2500 | 2018-03-29 Aperio ePathology IVD System CS2, includes; CS2 IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500 |
| 00815477020068 - eIHC IVD bundle AT Turbo-2500 | 2018-03-29 Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500 |