Identity
- Trade Name
- Adaptivo EUDAMEDStandard Imaging Adaptivo FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- Adaptivo EUDAMEDStandard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems. FDA UDI
- Model / Reference
- 91350 EUDAMEDv1 FDA UDI
- Description
- Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems. FDA UDI
Identifiers
- Catalog Number
- 91350 FDA UDI
- Primary DI / UDI-DI
- 00866562000243 EUDAMEDFDA UDI
- Basic UDI-DI
- 08665620002ADAPTIVONV EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010182 LINEAR ACCELERATORS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiation therapy software
Standard Imaging Adaptivo by Standard Imaging, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 b910bf27-b723-40ed-b1d2-19f7f541b8fd 34 fields · synced Jul 8, 2026
- EUDAMED a654c6cc-e647-4da5-9528-c61a96cacc9b 61 fields · synced Jul 8, 2026