FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
K Number: K242258
·
Decision Nov 26, 2024
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
4
Review Days
118
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Basic Information
- Device Name
- MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
- K Number
- K242258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Asg Superconductors S.P.A.
- Date Received
- July 31, 2024
- Decision Date
- November 26, 2024
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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