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510(k) K232325

RAYSCAN a-Expert by Ray Co., Ltd. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2024
Date Received
August 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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  • K192737 — RCT800 (October 22, 2019)
  • K190812 — RAYSCAN a-Expert3D (April 24, 2019)

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