RayStation 12A— 510(k) K222312

Substantially Equivalent

RaySearch Laboratories AB (PUBL)

FDA 510(k) clearance K222312 for RayStation 12A, Substantially Equivalent on 2023-03-29. Applicant: RaySearch Laboratories AB (PUBL).

Clearance details

Applicant: RaySearch Laboratories AB (PUBL)
Product code: Code MUJ
Advisory panel: Radiology
Date received: 2022-08-01
Decision date: 2023-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

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