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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 K211656
Device Name 3D Echo v1.1
Applicant
JointVue LLC
2450 E.J. Chapman Drive, Suite 104A
Knoxville,  TN  37996
Applicant Contact Maja Ward
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
IYO  
Date Received05/28/2021
Decision Date 06/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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