Cleared Traditional

ARIETTA x10

K231941 · Fujifilm Healthcare Americas Corporation · Radiology
Nov 2023
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K231941 is an FDA 510(k) clearance for the ARIETTA x10, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Fujifilm Healthcare Americas Corporation (Lexington, US). The FDA issued a Cleared decision on November 20, 2023, 143 days after receiving the submission on June 30, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K231941 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2023
Decision Date November 20, 2023
Days to Decision 143 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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