Identity
- Trade Name
- MRopen EVO FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- MROpen EVO 03-2000-00 v8 Whole body magnetic resonance diagnostic medical device intended for the production of images for diagnostic purposes with transverse, coronal, sagittal and oblique orientation relating to the internal structures of the examined body areas, also including the examination of the brain through the DWI sequence, with limitations regarding cardiac, breast, lung and upper abdominal imaging. FDA UDI
- Model / Reference
- 03-2000-00 v8 FDA UDI
- Description
- MROpen EVO 03-2000-00 v8 Whole body magnetic resonance diagnostic medical device intended for the production of images for diagnostic purposes with transverse, coronal, sagittal and oblique orientation relating to the internal structures of the examined body areas, also including the examination of the brain through the DWI sequence, with limitations regarding cardiac, breast, lung and upper abdominal imaging. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B5450320000080 FDA UDI
- 510(k) Number
- K242258 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Full-body MRI system, superconducting magnet
MRopen EVO by Asg Superconductors Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K242258 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Asg Superconductors Spa
Sources (1)
- FDA UDI 42c02bed-f7f3-43f6-aa5b-d8d67c87042e 34 fields · synced Jun 8, 2026