Cranial 4Pi Immobilization— 510(k) K243142
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K243142 for Cranial 4Pi Immobilization, Substantially Equivalent on 2025-06-23. 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
- Traditional
- Location
- Munich, DE
Recent devices under product code IYE
view allMore clearances from Brainlab AG
view all- K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K252562 — Spine & Trauma Navigation Instruments
- K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
- K250440 — RT Elements (4.5) +11 more
- K243633 — Brainlab Elements (7.0) +5 more
Adverse 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.