Cleared Traditional

8ch Flex Suite

K172222 · Shenzhen RF Tech Co., Ltd. · Radiology
Dec 2017
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K172222 is an FDA 510(k) clearance for the 8ch Flex Suite, 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 December 8, 2017, 137 days after receiving the submission on July 24, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K172222 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2017
Decision Date December 08, 2017
Days to Decision 137 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

Similar Devices — MOS Coil, Magnetic Resonance, Specialty

All 483
GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only
K252179 · Shenzhen RF Tech Co., Ltd. · Feb 2026
3.0T AIR 32CH HNA
K253738 · Ge Healthcare Coils (Usa Instruments, Inc.) · Jan 2026
dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
K254190 · Philips Medical Systems Nederland B.V. · Jan 2026
InkSpace Imaging Small Body Array (SBA12PH30x)
K253182 · Inkspace Imaging, Inc. · Oct 2025
e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
K243428 · Dxtx Medical, Inc. · Jul 2025
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
K244054 · Quality Electrodynamics · Feb 2025