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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K221478
Device Name Dolphin Blue Imaging
Applicant
Patterson Dental Supply, Inc.
Dolphin Imaging & Management Solutions
9200 Oakdale Ave. Suite 500
Chatsworth,  CA  91311
Applicant Contact Erin Daly
Correspondent
Patterson Dental Supply, Inc.
Dolphin Imaging & Management Solutions
9200 Oakdale Ave. Suite 500
Chatsworth,  CA  91311
Correspondent Contact Erin Daly
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/23/2022
Decision Date 11/01/2022
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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