Identity
- Trade Name
- KBA3D EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- KEOPS Balance Analyzer 3D EUDAMEDSpinal surgery planning software FDA UDI
- Model / Reference
- v1.1.x EUDAMEDFDA UDI
- Description
- Spinal surgery planning software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701313000479 EUDAMEDFDA UDI
- Basic UDI-DI
- 37013130KBA3DSFTWDB EUDAMED
- 510(k) Number
- K213975 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Kba3d by S.m.a.i.o — Class IIa — 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 | K223841 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 37013130KBA3DSFTWDB | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.m.a.i.o
- EUDAMED SRN
- FR-MF-000002399
Sources (3)
- EUDAMED aa23b859-a569-4810-818a-6508c9cd40b4 61 fields · synced Jul 16, 2026
- FDA UDI f3420f19-95de-4738-b5e0-becc48cb4dab 36 fields · synced May 30, 2026
- FDA 510(k) K223841 1 fields · synced May 18, 2026