Identity
- Trade Name
- Halcyon EUDAMEDFDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- Halcyon, Ethos Radiotherapy System EUDAMED
- Model / Reference
- Halcyon 4.0 EUDAMED4.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857235006075 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200108PQ EUDAMED
- 510(k) Number
- K222941 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010101 SINGLE ENERGY LINEAR ACCELERATORS EUDAMED
- GMDN Term
- Linear accelerator system FDA UDI
Classification
- Device Class
- Class IIb 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Halcyon by Varian Medical Systems, Inc — Class IIb — 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
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 | K181032 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K170817 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200108PQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED 19fbf98f-ea2c-41ef-8754-3563d98740b5 61 fields · synced Jul 23, 2026
- FDA UDI b9029780-0456-4e14-832f-c207ac8c97bf 33 fields · synced May 30, 2026
- FDA 510(k) K181032 1 fields · synced May 18, 2026