PlanOne 1— 510(k) K250963

Substantially Equivalent

Cosylab Jsc, Control System Laboratory

FDA 510(k) clearance K250963 for PlanOne 1, Substantially Equivalent on 2025-11-20. Applicant: Cosylab Jsc, Control System Laboratory.

Clearance details

Applicant: Cosylab Jsc, Control System Laboratory
Product code: Code MUJ
Advisory panel: Radiology
Date received: 2025-03-31
Decision date: 2025-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ljubljana, SI

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