510(k) K093117 ยท LLZ System, Image Processing, Radiological
DIGITAL LIGHTBOX
| Applicant | Brainlab AG, Feldkirchen, DE |
| Decision | Substantially Equivalent, Dec 11, 2009 |
| Received | Oct 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2015 | Brainlab AG Digital Lightbox, BrainLAB system, image processing, radiological
Product Usage:
The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to a Terminated |
LLZ | None listed |
| Jul 30, 2014 | Brainlab AG Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.