1.5T 16-CHANNEL HAND-WRIST COIL— 510(k) K103149

Clearance details

Applicant

Invivo Corporation

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2010-10-25

Decision date

2011-01-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Florida, FL, US

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• Z-0126-2021 — MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.Class III·Terminated·Invivo Corporation·20200914

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103149.