Cleared Traditional

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. · Radiology
Feb 2026
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K252179 is an FDA 510(k) clearance for the 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, 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 February 10, 2026, 214 days after receiving the submission on July 11, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K252179 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2025
Decision Date February 10, 2026
Days to Decision 214 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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