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510(k) K252179

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 by Shenzhen RF Tech Co., Ltd. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2026
Date Received
July 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Shenzhen RF Tech Co., Ltd.

  • K231085 — 1.5T HD T/R Knee Array (10-F34127) (August 18, 2023)
  • K223203 — 1.5T 24E Posterior Array (March 2, 2023)
  • K223225 — 8ch T/R Knee Coil (February 14, 2023)
  • K223239 — 8ch Wrist Coil (December 8, 2022)
  • K200836 — 8ch Flex Suite (July 22, 2020)
  • K172222 — 8ch Flex Suite (December 8, 2017)
  • K160932 — 8ch Foot Ankle Coil (August 1, 2016)
  • K160935 — 8ch Foot Ankle Coil (July 28, 2016)
  • K151653 — 8ch Foot Ankle Coil (August 7, 2015)

Other clearances for product code MOS

  • K253738 — 3.0T AIR 32CH HNA (January 23, 2026)
  • K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS Hea (January 14, 2026)
  • K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) (October 20, 2025)
  • K243428 — e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Co (July 17, 2025)
  • K244054 — 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247 (February 28, 2025)
  • K243675 — InkSpace Imaging Small Body Array (December 20, 2024)
  • K243316 — XENOVIEW 3.0T Chest Coil (November 19, 2024)
  • K243033 — dS Wrist coil 8ch 1.5T (October 18, 2024)
  • K242879 — dS Knee Coil 8ch 1.5T (October 18, 2024)
  • K242096 — dS FootAnkle Coil 8ch 1.5T (August 12, 2024)