Identity
- Trade Name
- DoseVieew 3D EUDAMEDStandard Imaging DoseView 3D FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- QA Water Phantom EUDAMEDStandard Imaging DoseView 3D is a medical device intended for performing water phantom based commissioning and QA measurements on radiation therapy systems. FDA UDI
- Model / Reference
- 92260 EUDAMEDFDA UDI
- Description
- Standard Imaging DoseView 3D is a medical device intended for performing water phantom based commissioning and QA measurements on radiation therapy systems. FDA UDI
Identifiers
- Catalog Number
- 92260 FDA UDI
- Primary DI / UDI-DI
- 00866562000205 EUDAMEDFDA UDI
- Basic UDI-DI
- 08665620002DOSEVIEWZD EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- France 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
Yes
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
Category: Accelerator system quality assurance device
Standard Imaging DoseView 3D by Standard Imaging, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Accelerator system quality assurance device.
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- myQA®Daily (Software) — IBA Dosimetry GmbH · Class I
- Vista — Modus Medical Devices Inc · Class I
- TomoDose — Sun Nuclear Corporation · Class I
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
- Standard Imaging, Inc.
Sources (2)
- FDA UDI 39dd0e81-38ba-4daf-9c48-d562346c3d7e 34 fields · synced Aug 4, 2026
- EUDAMED 7d1c048a-de8e-47a6-8733-181bf086e431 61 fields · synced Aug 4, 2026