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ExacTrac Dynamic, 2.0
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 48520510(k) K254010
by Brainlab SE
Identity
- Trade Name
- ExacTrac Dynamic, 2.0 EUDAMEDExacTrac Dynamic FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- ExacTrac Dynamic EUDAMED
- Model / Reference
- 48520 EUDAMED2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144609 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481ExacTracEU EUDAMED
- 510(k) Number
- K240431 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- 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
ExacTrac Dynamic, 2.0 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 | K254010 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4056481ExacTracEU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (3)
- EUDAMED 5bc30b04-3426-47b8-8713-505c14d8229a 85 fields · synced Jun 19, 2026
- FDA UDI 4af9f8bf-9c20-472c-baee-64079864ff34 33 fields · synced May 30, 2026
- FDA 510(k) K254010 1 fields · synced Jun 9, 2026