9 devices · 1 company · 2023 to 2025
Brainlab AG: AI-enabled devices on FDA's list
9 devices from Brainlab AG, 2023 to 2025, from 1 company across 5 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (9 of 9 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Brainlab AG
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| RT ElementsK250440 · 510(k) | Radiology | MUJ | database entry | |
| Brainlab ElementsK243633 · 510(k) | Radiology | QIH | database entry | |
| Automatic RegistrationK234047 · 510(k) | Neurology | OLO | database entry | |
| Alignment System Cranial, Alignment Software CraK223864 · 510(k) | Neurology | HAW | database entry | |
| Spine PlanningK223553 · 510(k) | Neurology | OLO | database entry | |
| Cranial Navigation, Navigation Software Cranial,K223288 · 510(k) | Neurology | HAW | database entry | |
| Brainlab Elements Image Fusion, ContouringK223106 · 510(k) | Radiology | QIH | database entry | |
| ENT EMK223734 · 510(k) | Neurology | PGW | database entry | |
| Brainlab Elements Trajectory PlanningK223552 · 510(k) | Neurology | HAW | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.