Devices · Samsung Medison CO., LTD.

HS40 Diagnostic Ultrasound System

Samsung Medison CO., LTD. is listed for HS40 Diagnostic Ultrasound System (K210426). The FDA list gives May 13, 2021 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYN. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210426

Official FDA database record

Date of final decision

May 13, 2021

Company on the FDA list

Samsung Medison CO., LTD.

Lead panel

Radiology

Primary product code

IYN

openFDA device name for the code

System, Imaging, Pulsed Doppler, Ultrasonic

Device class

2

Regulation number

892.1550

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary