Cleared Traditional

COLORMARK(TM) VISUALIZATION SYSTEM

K926351 · Echocath, Inc. · Radiology
Sep 1993
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K926351 is an FDA 510(k) clearance for the COLORMARK(TM) VISUALIZATION SYSTEM, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Echocath, Inc. (Princeton, US). The FDA issued a Cleared decision on September 16, 1993, 273 days after receiving the submission on December 17, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K926351 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1992
Decision Date September 16, 1993
Days to Decision 273 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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