Identity
- Trade Name
- CNERGY TBI Detector EUDAMEDTBI Detector 110V FDA UDI
- Generic Name
- Radiation therapy digital imager FDA UDI
- Device Name
- TBI Detector EUDAMEDThe TBI Detector is used in radiation therapy clinics to acquire MV images by means of an imaging device, in order to be forwarded to the Theraview imaging software. FDA UDI
- Model / Reference
- C01-05-02 EUDAMEDFDA UDI
- Description
- The TBI Detector is used in radiation therapy clinics to acquire MV images by means of an imaging device, in order to be forwarded to the Theraview imaging software. FDA UDI
Identifiers
- Catalog Number
- C01-05-02 FDA UDI
- Primary DI / UDI-DI
- 08717953004017 EUDAMED08717953004031 FDA UDI
- Basic UDI-DI
- 87179530040C01-05-02YX EUDAMED
- Direct Marketing DI
- 08717953004017 EUDAMED
- 510(k) Number
- K960510 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11039021 RADIOGRAPHY VIDEO ACQUISITION SYSTEMS EUDAMED
- GMDN Term
- Radiation therapy digital imager FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
CNERGY TBI Detector by Cablon Medical B.V. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 87179530040C01-05-02YX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cablon Medical B.V.
- EUDAMED SRN
- NL-MF-000002582
Sources (2)
- EUDAMED 4759ed3e-2ab2-4d86-95e9-a5f22f01b63a 61 fields · synced Jun 19, 2026
- FDA UDI 081da2e2-2a3f-48dd-8754-69daedadc588 36 fields · synced May 27, 2026