Cleared Special

STN PROBE

K101816 · Summit Doppler Systems, Inc. · Radiology
Aug 2010
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K101816 is an FDA 510(k) clearance for the STN PROBE, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Summit Doppler Systems, Inc. (Golden, US). The FDA issued a Cleared decision on August 19, 2010, 50 days after receiving the submission on June 30, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K101816 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2010
Decision Date August 19, 2010
Days to Decision 50 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code ITX — Transducer, Ultrasonic, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570

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