FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
K Number: K254010
·
Decision Jan 14, 2026
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
1
Review Days
30
Basic Information
- Device Name
- ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
- K Number
- K254010
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brainlab SE
- Date Received
- December 15, 2025
- Decision Date
- January 14, 2026
- Product Code
- IYE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYE), ordered by most recent decision date.
ThinkQA 3
FDA 510(k)
FDA Class 2
·Radiology
LUNA 3D
FDA 510(k)
FDA Class 2
·Radiology
AerFrame Patient Immobilization System (AFPIS)
FDA 510(k)
FDA Class 2
·Radiology
VERIQA RT EPID 3D
FDA 510(k)
FDA Class 2
·Radiology
ClearCheck (RADCC V2.7)
FDA 510(k)
FDA Class 2
·Radiology
AlignRT Plus (8.0)
FDA 510(k)
FDA Class 2
·Radiology