Cleared Traditional

Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System

K192879 · Edan Instruments, Inc. · Radiology
May 2020
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K192879 is an FDA 510(k) clearance for the Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on May 21, 2020, 234 days after receiving the submission on September 30, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K192879 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2019
Decision Date May 21, 2020
Days to Decision 234 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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