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510(k) K241266

Imaging system of positron emission and X-ray computed tomography (DigitMI 930) by Raysolution Healthcare Co., Ltd. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2025
Date Received
May 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

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