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510(k) K250318

Planmed XFI by Planmed OY — Product Code SFV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2025
Date Received
February 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
X-Ray, Computed Tomography, Cone-Beam
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.

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