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510(k) K250738

YSIO X.pree by Siemens Medical Solutions — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2025
Date Received
March 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K070629 — FLEX AND LOOP COIL SET 1.5 T (March 26, 2007)

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