Cleared Traditional

ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2

K142197 · Konica Minolta, Inc. · Radiology
Nov 2014
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K142197 is an FDA 510(k) clearance for the ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Konica Minolta, Inc. (Hino-Shi, JP). The FDA issued a Cleared decision on November 21, 2014, 102 days after receiving the submission on August 11, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K142197 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2014
Decision Date November 21, 2014
Days to Decision 102 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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