Identity
- Trade Name
- MIMI Phantom EUDAMEDStandard Imaging MIMI Phantom FDA UDI
- Generic Name
- Multi-modality therapeutic radiation phantom, test object FDA UDI
- Device Name
- MIMI Phantom EUDAMEDStandard Imaging MIMI (Multiple Imaging Modality Isocentricity) Phantom is designed for daily or weekly quality assurance of the geometric accuracy of the isocenter described by several systems included on many modern linear accelerators: the positioning lasers, the kV imaging system, the MV treatment beam and for Elekta and Varian optical guidance systems as well. FDA UDI
- Model / Reference
- 91240 EUDAMEDFDA UDI
- Description
- Standard Imaging MIMI (Multiple Imaging Modality Isocentricity) Phantom is designed for daily or weekly quality assurance of the geometric accuracy of the isocenter described by several systems included on many modern linear accelerators: the positioning lasers, the kV imaging system, the MV treatment beam and for Elekta and Varian optical guidance systems as well. FDA UDI
Identifiers
- Catalog Number
- 91240 FDA UDI
- Primary DI / UDI-DI
- 00850019946512 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946MIMIPHANTOMAV 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 MIMI Phantom by Standard Imaging, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 421255cb-2d72-4423-9a29-eadfc13dd147 34 fields · synced Jun 18, 2026
- EUDAMED a316f919-3451-49a1-b496-9507aaa180bc 61 fields · synced Jun 18, 2026