K243132

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)

510(k) number: K243132
Device name: Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)
Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd. CN
Product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Decision date: 2024-12-10
Date received: 2024-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Radiology

PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K243132.pdf

Official FDA record: K243132

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.