510(k) · Radiology

HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System

by Samsung Medison Co., LTD

HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System is an AI-enabled medical device from Samsung Medison Co., LTD that the U.S. FDA cleared through 510(k) K220043 on April 5, 2022. Its lead review panel is Radiology and its primary product code is IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

See also FDA-cleared AI radiology devices in 2022, all FDA AI clearances in 2022, top radiology AI devices.

Key facts

Submission numberK220043
Pathway510(k)
Date of final decision
Company (FDA list)Samsung Medison Co., LTD
Lead review panelRadiology
Primary product codeIYN — System, Imaging, Pulsed Doppler, Ultrasonic
Applicant (openFDA)Samsung Medison Co., Ltd.
Applicant locationHongcheon-Gun, KR
Device classClass 2
Regulation number21 CFR 892.1550
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System went through this pathway (K220043).

openFDA lists it as a Class 2 device under 21 CFR 892.1550. Class II devices are moderate risk and are subject to general and special controls.

Product code IYN covers 124 devices on the FDA AI list. By decision date, this device is #28 of 124 under that code. Samsung Medison Co., LTD has 18 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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