Identity
- Trade Name
- HexaPOD Enable Switch Board EUDAMEDHexaPOD FDA UDI
- Generic Name
- Accelerator system table, powered FDA UDI
- Device Name
- HexaPOD evo RT System EUDAMEDHexaPOD™ Enable Switch Board enables the HexaPOD™ evo Module to execute a movement command FDA UDI
- Model / Reference
- P10602-132 EUDAMEDFDA UDI
- Description
- HexaPOD™ Enable Switch Board enables the HexaPOD™ evo Module to execute a movement command FDA UDI
Identifiers
- Catalog Number
- P10602-132 FDA UDI
- Primary DI / UDI-DI
- 04056719001681 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000005J4 EUDAMED
- Direct Marketing DI
- 04056719001681 EUDAMED
- 510(k) Number
- K072898 FDA UDI
- FDA Product Code
- JAI FDA UDI
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
- GMDN Term
- Accelerator system table, powered FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5770 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Category: Accelerator system table, powered
HexaPOD by 3C-Medical Intelligence GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- 3C-Medical Intelligence GmbH
Sources (2)
- FDA UDI e6bc91d0-ea51-4310-92cf-6761f45aa01e 35 fields · synced Jul 11, 2026
- EUDAMED 2365917b-3d68-4ab0-8741-4c4c91000a24 61 fields · synced Jul 11, 2026