DIGITAL LIGHTBOX— 510(k) K093117
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K093117 for DIGITAL LIGHTBOX, Substantially Equivalent on 2009-12-11. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Applicant
- Brainlab AG
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Feldkirchen, DE
Recent devices under product code LLZ
view allMore clearances from Brainlab AG
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K093117
K-number listed on FDA's recall record- Z-0218-2016 — 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 and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
- Z-2134-2014 — 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. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093117.
Data sourced from openFDA. This site is unofficial and independent of the FDA.