Cleared Traditional

M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER

K002470 · Agilent Technologies, Inc. · Radiology
Sep 2000
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K002470 is an FDA 510(k) clearance for the M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on September 8, 2000, 28 days after receiving the submission on August 11, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K002470 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2000
Decision Date September 08, 2000
Days to Decision 28 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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