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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K222198
Device Name Exo Iris (El2001)
Applicant
Exo Imaging, Inc.
4201 Burton Dr.
Santa Clara,  CA  95054
Applicant Contact Antoanela Gomard
Correspondent
Exo Imaging, Inc.
4201 Burton Dr.
Santa Clara,  CA  95054
Correspondent Contact Antoanela Gomard
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/22/2022
Decision Date 11/09/2022
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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