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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 K241949
Device Name Digital Color Doppler Ultrasound System (P60 Series)
Applicant
Sonoscape Medical Corp
Rm. 201 & 202, 12th Bldg, Shenzhen Software Park Phase Ii
1 Keji Middle 2nd Rd., Yuehai Subdistrict, Nanshan District
Shenzhen,  CN 518057
Applicant Contact Toki Wu
Correspondent
Sonoscape Medical Corp
Rm. 201 & 202, 12th Bldg, Shenzhen Software Park Phase Ii
1 Keji Middle 2nd Rd., Yuehai Subdistrict, Nanshan District
Shenzhen,  CN 518057
Correspondent Contact Toki Wu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/03/2024
Decision Date 01/17/2025
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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