Cleared Traditional

ABSOLU

K183414 · Quantel Medical · Radiology
Mar 2019
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K183414 is an FDA 510(k) clearance for the ABSOLU, 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 March 20, 2019, 100 days after receiving the submission on December 10, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K183414 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2018
Decision Date March 20, 2019
Days to Decision 100 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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