FDA UDI
In Commercial Distribution
🇺🇸 United States
ScanX Swift View 2.0
DI: E247G8900
·
Model: XPS07.2A1
·
DÜRR DENTAL SE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ScanX Swift View 2.0
- Primary DI
- E247G8900
- Version / Model
- XPS07.2A1
- Catalog Number
- G8900, G8900A
- Company Name
- DÜRR DENTAL SE
- Labeler DUNS
- 315563684
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-27
- Public Version
- 2
- Public Version Date
- 2024-07-25
- Public Version Status
- Update
- Public Device Record Key
- daa0b0a7-6905-4136-9663-36875fc3f19b
Device Description
Dental Image Plate Scanner
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
- Yes
- 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 |
|---|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45257 | Dental computed radiography digital imaging scanner | A device/device assembly designed to be used with an analogue dental x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). The image is acquired on a photostimulable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner; this device is dedicated to dental use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E247G8900 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230095 | 000 |