Cleared Traditional

Pocket III

K232302 · Quantel Medical · Radiology
Apr 2024
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K232302 is an FDA 510(k) clearance for the Pocket III, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Quantel Medical (Cournon D' Auvergne-Cedex, FR). The FDA issued a Cleared decision on April 26, 2024, 269 days after receiving the submission on August 1, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K232302 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2023
Decision Date April 26, 2024
Days to Decision 269 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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