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DoseRT reference board
EUDAMEDFDA UDIClass I (EU MDR)
Ref DoseRT reference boardModel DoseRT Camera
Identity
- Trade Name
- DoseRT reference board EUDAMEDFDA UDI
- Generic Name
- Radiological video camera patient positioning/tracking system FDA UDI
- Device Name
- DoseRT Camera EUDAMEDDoseRT reference board used with AlignRT Plus systems. FDA UDI
- Model / Reference
- DoseRT Camera EUDAMEDDoseRT reference board EUDAMEDFDA UDI
- Description
- DoseRT reference board used with AlignRT Plus systems. FDA UDI
Identifiers
- Catalog Number
- DoseRT reference board FDA UDI
- Primary DI / UDI-DI
- 05056190500894 EUDAMEDFDA UDI
- Basic UDI-DI
- 5056190501075UY EUDAMED
- Direct Marketing DI
- 05056190500894 EUDAMED
- 510(k) Number
- K233622 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological video camera patient positioning/tracking system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Denmark 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
DoseRT reference board by Vision RT Ltd. — Class I — 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 | 5056190501075UY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vision RT Ltd.
- EUDAMED SRN
- GB-MF-000010499
- Authorised Representative
- Oticon A/S DK-AR-000006135
Sources (2)
- EUDAMED d2c0b78f-a66d-4272-9fba-2aa9d5f15a64 61 fields · synced Jul 26, 2026
- FDA UDI bfc4b300-baa3-4f1b-92ae-af67197486be 35 fields · synced May 30, 2026