Cleared Traditional

VISTA AVS

K063600 · Summit Doppler Systems, Inc. · Radiology
Dec 2006
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K063600 is an FDA 510(k) clearance for the VISTA AVS, a Monitor, Ultrasonic, Nonfetal (Class II — Special Controls, product code JAF), submitted by Summit Doppler Systems, Inc. (Golden, US). The FDA issued a Cleared decision on December 19, 2006, 15 days after receiving the submission on December 4, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number K063600 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2006
Decision Date December 19, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAF — Monitor, Ultrasonic, Nonfetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1540