FDA UDI
In Commercial Distribution
🇺🇸 United States
Radlink Laser Pro 16
DI: 00866389000167
·
Model: LP100
·
RADLINK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Radlink Laser Pro 16
- Primary DI
- 00866389000167
- Version / Model
- LP100
- Company Name
- RADLINK, INC.
- Labeler DUNS
- 069190036
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2018-08-23
- Public Version Status
- Update
- Public Device Record Key
- 89642757-ce73-4828-a02d-bc6799f6d3a7
Device Description
The Radlink Laser Pro 16 is a film digitization system that follows a three-step process of acquiring, selecting, and sending digitized films to any desired destination. A laser beam light source and a sealed optic path are used to scan the film that is driven by a clocked, stepping motor. It utilizes a 12-film auto loader, and its software provides image quality control and post-processing functions and enables distribution and routing of DICOM images through a healthcare network.
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LMA | Digitizer, Image, Radiological | Radiology | 892.2030 | 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 | 00866389000167 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020243 | 000 |