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Brainlab Elements Image Fusion, 5.0
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 04056481145873510(k) K243633
by Brainlab SE
Identity
- Trade Name
- Brainlab Elements Image Fusion, 5.0 EUDAMEDImage Fusion FDA UDI
- Generic Name
- Stereotactic system application software FDA UDI
- Device Name
- Brainlab Elements Image Fusion EUDAMED
- Model / Reference
- 04056481145873 EUDAMED5.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481145873 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481FusionP4 EUDAMED
- Direct Marketing DI
- 04056481145873 EUDAMED
- 510(k) Number
- K243633 FDA UDI
- FDA Product Code
- QIH FDA UDIJAK FDA UDILLZ FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Stereotactic system application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1750 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Brainlab Elements Image Fusion, 5.0 by Brainlab SE — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243633 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4056481FusionP4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
- FDA Applicant
- Brainlab AG
Sources (3)
- EUDAMED 76ea456d-d45d-4b72-b188-882b2ede1f9a 85 fields · synced Jun 19, 2026
- FDA UDI eee418df-1aae-4045-97a7-944a86a5cd7d 33 fields · synced May 30, 2026
- FDA 510(k) K243633 1 fields · synced May 18, 2026