SET-5002— 510(k) K240827

Name: FDA 510(k) clearance K240827
Creator: U.S. Food and Drug Administration
Published: 2024-05-24

Substantially Equivalent

Shimadzu Corporation Medical Systems Division

FDA 510(k) clearance K240827 for SET-5002, Substantially Equivalent on 2024-05-24. Applicant: Shimadzu Corporation Medical Systems Division. Device class: 2.

Clearance details

Applicant: Shimadzu Corporation Medical Systems Division
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2024-03-26
Decision date: 2024-05-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kyoto, JP

Download summary PDF View on FDA.gov ↗

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