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510(k) K252133

Adaptix Ortho350 by Adaptix Limited — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2025
Date Received
July 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

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