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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 K221568
Device Name KOLO Evolution XHD Series Ultrasound Diagnostic System
Applicant
Kolo Medical (Suzhou) Co., Ltd.
Rm. 303-305 And 504, Bldg. A5, # 218 Xinghu St.
Suzhou,  CN 215123
Applicant Contact Mike SU
Correspondent
Kolo Medical (Suzhou) Co., Ltd.
Rm. 303-305 And 504, Bldg. A5, # 218 Xinghu St.
Suzhou,  CN 215123
Correspondent Contact Mike SU
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/31/2022
Decision Date 09/12/2022
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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