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510(k) K251438

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) by Guilin Woodpecker Medical Instrument Co., Ltd. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2025
Date Received
May 9, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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