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510(k) K251004

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) by Hefei Chimed Intelligent Machine Co., Ltd. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2025
Date Received
April 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image-Intensified Fluoroscopic X-Ray System, Mobile
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Fluoroscopy of the human body.

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