Identity
- Trade Name
- CNERGY Go! EUDAMEDPIM Fixed Hand Palm Scanner FDA UDI
- Generic Name
- Radiation therapy treatment record/verify system FDA UDI
- Device Name
- Patient Identification Module (PIM) EUDAMEDThe Patient Identification Module (PIM) is used in radiation therapy clinics to verify the patient's identity prior to treatment by means of a portable sensor, in order to prevent patient mix-ups. An interlock disables the LINAC and treatment will not start so long as the patient is not successfully identified. FDA UDI
- Model / Reference
- C01-09 EUDAMEDC01-09-02 FDA UDI
- Description
- The Patient Identification Module (PIM) is used in radiation therapy clinics to verify the patient's identity prior to treatment by means of a portable sensor, in order to prevent patient mix-ups. An interlock disables the LINAC and treatment will not start so long as the patient is not successfully identified. FDA UDI
Identifiers
- Catalog Number
- C01-09-02 FDA UDI
- Primary DI / UDI-DI
- 08717953004048 EUDAMEDFDA UDI
- Basic UDI-DI
- 87179530040C01-09QV EUDAMED
- 510(k) Number
- K960510 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiation therapy treatment record/verify system FDA UDI
Classification
- Device Class
- Class I 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
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
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
Category: Accelerator system quality assurance device
CNERGY Go! by Cablon Medical B.V. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 87179530040C01-09QV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cablon Medical B.V.
- EUDAMED SRN
- NL-MF-000002582
Sources (2)
- EUDAMED de125fc4-4a99-4c2e-ace1-e5f1ccc6444a 61 fields · synced Jul 26, 2026
- FDA UDI c4626afe-ed38-42f9-89e7-505308167915 37 fields · synced May 30, 2026