Cleared Traditional

8ch Foot Ankle Coil

K160935 · Shenzhen RF Tech Co., Ltd. · Radiology
Jul 2016
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K160935 is an FDA 510(k) clearance for the 8ch Foot Ankle Coil, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Shenzhen RF Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 28, 2016, 115 days after receiving the submission on April 4, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K160935 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2016
Decision Date July 28, 2016
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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