FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
K Number: K243633
·
Decision Jun 13, 2025
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
216
Applicant Total
47
Review Days
200
Basic Information
- Device Name
- Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
- K Number
- K243633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brainlab AG
- Date Received
- November 25, 2024
- Decision Date
- June 13, 2025
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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|---|---|---|---|
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| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | May 23, 2024 | Substantially Equivalent |
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| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Aug 2, 2023 | Substantially Equivalent |