Medical Device Manufacturer · CN , Shenzhen

Shenzhen Wisonic Medical Technology Co. , Ltd. - FDA 510(k) Cleared D...

7 submissions · 7 cleared · Since 2018

Recent clearances: Carnation series Diagnostic Ultrasound System, Clivia series Diagnostic Ultrasound System, Labat series Diagnostic Ultrasound System

7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Shenzhen Wisonic Medical Technology Co. , Ltd. Radiology ✕

7 devices
1-7 of 7
Cleared Sep 15, 2023
Carnation series Diagnostic Ultrasound System
K230066 · IYN
Radiology · 249d
Cleared Dec 02, 2021
Clivia series Diagnostic Ultrasound System
K211886 · IYN
Radiology · 164d
Cleared Jul 30, 2021
Labat series Diagnostic Ultrasound System
K210154 · IYN
Radiology · 190d
Cleared Feb 07, 2020
Paragon XHD Diagnostic Ultrasound System
K191347 · IYN
Radiology · 263d
Cleared Nov 20, 2018
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
K182715 · IYN
Radiology · 54d
Cleared May 09, 2018
Navi e/Navi s/Navi X Diagnostic Ultrasound System
K180461 · IYN
Radiology · 78d
Cleared Jan 02, 2018
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
K163712 · IYN
Radiology · 368d
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