1.5T and 3.0T 16 CH GE Shoulder Coils— 510(k) K162001

Clearance details

Applicant

Invivo Corporation

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2016-07-20

Decision date

2016-08-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Florida, FL, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162001.