Cleared Traditional

MyLabSix CrystaLine

K162290 · Esaote, S.P.A. · Radiology
Oct 2016
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K162290 is an FDA 510(k) clearance for the MyLabSix CrystaLine, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Esaote, S.P.A. (Genova, IT). The FDA issued a Cleared decision on October 14, 2016, 60 days after receiving the submission on August 15, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K162290 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2016
Decision Date October 14, 2016
Days to Decision 60 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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