Identity
- Trade Name
- Radlink Laser Pro 16 FDA UDI
- Generic Name
- Radiography digital imaging scanner FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- LP100 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866389000167 FDA UDI
- 510(k) Number
- K020243 FDA UDI
- FDA Product Code
- LMA FDA UDI
- GMDN Term
- Radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiography digital imaging scanner
Radlink Laser Pro 16 by Radlink, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Radlink, Inc.
Sources (1)
- FDA UDI 89642757-ce73-4828-a02d-bc6799f6d3a7 34 fields · synced May 30, 2026