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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K241249
Device Name Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)
Applicant
Palodex Group Oy
Nahkelantie 160
Tuusula,  FI 04300
Applicant Contact Riika Sarviaho
Correspondent
Palodex Group Oy
Nahkelantie 160
Tuusula,  FI 04300
Correspondent Contact Riika Sarviaho
Regulation Number892.1750
Classification Product Code
OAS  
Date Received05/03/2024
Decision Date 09/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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