510(k) K092467 ยท HAW Neurological Stereotaxic Instrument
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
| Applicant | Brainlab AG, Feldkirchen, DE |
| Decision | Substantially Equivalent, May 6, 2010 |
| Received | Aug 12, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092467
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2020 | Brainlab AG Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system t Terminated |
HAW | None listed |
| Jan 19, 2016 | Brainlab AG Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments.
The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localizatio Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.