FDA UDI
In Commercial Distribution
🇺🇸 United States
Aperio GT 450 DX (US) Scanner
DI: 00815477020525
·
Model: 23GT450DXUS
·
LEICA BIOSYSTEMS IMAGING, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aperio GT 450 DX (US) Scanner
- Primary DI
- 00815477020525
- Version / Model
- 23GT450DXUS
- Company Name
- LEICA BIOSYSTEMS IMAGING, INC
- Labeler DUNS
- 063440460
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-31
- Public Version
- 2
- Public Version Date
- 2024-06-27
- Public Version Status
- Update
- Public Device Record Key
- a9a6217c-ef4c-4359-8f76-4bc77fff1c55
Device Description
Aperio 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 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 | 00815477020525 | GS1 |
Customer Contacts
- Phone
- +1(866)4783999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232202 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify