ExacTrac Dynamic 1.1.2— 510(k) K231052
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K231052 for ExacTrac Dynamic 1.1.2, Substantially Equivalent on 2023-05-11. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Applicant
- Brainlab AG
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Munich, DE
Recent devices under product code IYE
view allMore clearances from Brainlab AG
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.