FDA UDI
In Commercial Distribution
🇺🇸 United States
MRopen EVO
DI: B5450320000080
·
Model: 03-2000-00 v8
·
ASG SUPERCONDUCTORS SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MRopen EVO
- Primary DI
- B5450320000080
- Version / Model
- 03-2000-00 v8
- Company Name
- ASG SUPERCONDUCTORS SPA
- Labeler DUNS
- 438236494
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-18
- Public Version
- 1
- Public Version Date
- 2024-12-26
- Public Version Status
- New
- Public Device Record Key
- 42c02bed-f7f3-43f6-aa5b-d8d67c87042e
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37654 | Full-body MRI system, superconducting magnet | A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B5450320000080 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242258 | 000 |