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Digital Color Doppler Ultrasound Imaging System - Di

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243178

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identifiers

510(k) Number
K243178 FDA 510(k)
FDA Product Code
IYN FDA 510(k)
Models / Variants
Digital Color Doppler Ultrasound Imaging System (Apogee C1) FDA 510(k)
Digital Color Doppler Ultrasound Imaging System (Apogee C2) FDA 510(k)
Digital Color Doppler Ultrasound Imaging System (Apogee C3) FDA 510(k)
Digital Color Doppler Ultrasound Imaging System (Apogee C5) FDA 510(k)
Digital Color Doppler Ultrasound Imaging System (Apogee K1) FDA 510(k)
Digital Color Doppler Ultrasound Imaging System (Apogee K2) FDA 510(k)
Digital Color Doppler Ultrasound Imaging System (Apogee K3) FDA 510(k)
Digital Color Doppler Ultrasound Imaging System (Apogee K5) FDA 510(k)
Di FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Digital Color Doppler Ultrasound Imaging System - Di by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 9…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shantou Institute of Ultrasonic Instruments Co., Ltd.

Sources (1)

  • FDA 510(k) K243178 24 fields · synced Jun 18, 2026