Home › RADLINK, INC. › Radlink Laser Pro 16
Radlink Laser Pro 16
RADLINK, INC. · Model LP100 · UDI-DI 00866389000167
1
510(k) clearances
5
Adverse events
2
Recalls
8
Facilities
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-25 | Brainlab AG | The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if us |
| 2005-03-30 | Konica Medical Imaging, Inc. | One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.