FDA UDI
In Commercial Distribution
🇺🇸 United States
ScanX Ortho
DI: D678F37500
·
Model: F3750
·
AIR TECHNIQUES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ScanX Ortho
- Primary DI
- D678F37500
- Version / Model
- F3750
- Company Name
- AIR TECHNIQUES, INC.
- Labeler DUNS
- 043835081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2018-08-23
- Public Version Status
- Update
- Public Device Record Key
- df1ab1e6-b9cf-49c7-a643-33c99d111411
Device Description
Scan X Ortho Digital Imaging System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| MUH | System,X-Ray,Extraoral Source,Digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35928 | Radiography digital imaging scanner | A laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D678F37500 | HIBCC |
Customer Contacts
- Phone
- 800-247-8324
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013893 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 24.5 | Inch | |
| Depth | 15.5 | Inch | |
| Width | 15.5 | Inch |