Standard Imaging Stereotactic Dose Verification Phantom
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Stereotactic Dose Verification Phantom EUDAMEDStandard Imaging Stereotactic Dose Verification Phantom FDA UDI
- Generic Name
- Multi-modality therapeutic radiation phantom, test object FDA UDI
- Device Name
- SDVP Phantom EUDAMEDStandard Imaging Stereotactic Dose Verification Phantom can be used for a wide variety of tests including routine absolute dosimetry output checks and treatment planning system(TPS) commissioning and quality assurance(QA) tests as recommended by TG 53 and IEC 430 Treatment Planning System Commissioning and QA Standards. Patient specific dosimetry tests can be performed easily as well. FDA UDI
- Model / Reference
- 91250 EUDAMEDFDA UDI
- Description
- Standard Imaging Stereotactic Dose Verification Phantom can be used for a wide variety of tests including routine absolute dosimetry output checks and treatment planning system(TPS) commissioning and quality assurance(QA) tests as recommended by TG 53 and IEC 430 Treatment Planning System Commissioning and QA Standards. Patient specific dosimetry tests can be performed easily as well. FDA UDI
Identifiers
- Catalog Number
- 91250 FDA UDI
- Primary DI / UDI-DI
- 00850019946529 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946SDVPHANTOMNS EUDAMED
- FDA Product Code
- IXG FDA UDI
- EMDN Code
- Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multi-modality therapeutic radiation phantom, test object FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1950 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Multi-modality therapeutic radiation phantom, test object
Standard Imaging Stereotactic Dose Verification Phantom by Standard Imaging, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (2)
- FDA UDI bf7b4dd1-89b3-41c9-b0f4-43aefe85b6b0 34 fields · synced Jul 15, 2026
- EUDAMED fc50eb7b-e823-4ccd-bf14-a5243cf9af58 61 fields · synced Jul 15, 2026