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TraumaCad Neo (1.1)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
510(k) K243810Ref 07290109943008
Identity
- Trade Name
- TraumaCad Neo EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- TraumaCad EUDAMED
- Model / Reference
- 07290109943008 EUDAMED1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109943008 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010994TraumaCadRY EUDAMED
- FDA Product Code
- QIH FDA 510(k)LLZ FDA UDI
- EMDN Code
- Z12139082 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Yes
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
TraumaCad Neo (1.1) by Brainlab Ltd. — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243810 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab Ltd.
- FDA Applicant
- Brainlab , Ltd.
Sources (3)
- FDA 510(k) K243810 24 fields · synced Jul 9, 2026
- FDA UDI 5cfa8c69-6a89-431e-8756-bb967d99f538 34 fields · synced May 30, 2026
- EUDAMED 9b169cce-cace-4d83-9e8c-eb6bcf0f5d16 61 fields · synced Jul 9, 2026