RayStation (2024A SP3)— 510(k) K252109

Substantially Equivalent

RaySearch Laboratories AB (PUBL)

FDA 510(k) clearance K252109 for RayStation (2024A SP3), Substantially Equivalent on 2025-12-22. Applicant: RaySearch Laboratories AB (PUBL).

Clearance details

Applicant: RaySearch Laboratories AB (PUBL)
Product code: Code MUJ
Advisory panel: Radiology
Date received: 2025-07-07
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

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