AIR Anterior Array, AIR Posterior Array— 510(k) K172695

Clearance details

Applicant

Ge Healthcare Coils (Usa Instruments, Inc.)

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2017-09-07

Decision date

2017-11-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Aurora, OH, US

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• Z-0062-2020 — AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.Class II·Terminated·GE Healthcare, LLC·20190319

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172695.