MRI Planner— 510(k) K211841
Substantially EquivalentSpectronic Medical AB
FDA 510(k) clearance K211841 for MRI Planner, Substantially Equivalent on 2022-08-25. Applicant: Spectronic Medical AB. Device class: 2.
Clearance details
- Applicant
- Spectronic Medical AB
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Helsingborg, SE
Recent devices under product code MUJ
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