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…
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.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for Radlink Laser Pro 16 | Listed by | Radlink, Inc., United States |
| FDA product code | LMA |
| Device type | Digitizer, Image, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2030 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K020243 |
| Record published | 2016-09-21 |
| Record revised | 2018-08-23 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.