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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 K212400
Device Name SONON Ultrasound Imaging System, Model: SONON 500L
Applicant
Healcerion Co., Ltd.
1403-Ho, 12, Digital-Ro 33-Gil, Guro-Gu
Seoul,  KR 08377
Applicant Contact Sooyeol Lee
Correspondent
Gms Consulting
4th Floor, Digital Cube, 34,
Sangamsan-Ro Mapo-Gu
Seoul,  KR 03909
Correspondent Contact Jong Hyun Kim
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/02/2021
Decision Date 04/22/2022
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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