PlanOne 1— 510(k) K250963
Substantially EquivalentCosylab Jsc, Control System Laboratory
FDA 510(k) clearance K250963 for PlanOne 1, Substantially Equivalent on 2025-11-20. Applicant: Cosylab Jsc, Control System Laboratory. Device class: 2.
Clearance details
- Applicant
- Cosylab Jsc, Control System Laboratory
- 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
- Ljubljana, SI
Recent devices under product code MUJ
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