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510(k) K143389

3.0T GEM RT Open Array by Ge Healthcare Coils (Usa Instruments, Inc.) — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2015
Date Received
November 26, 2014
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 Ge Healthcare Coils (Usa Instruments, Inc.)

  • K253738 — 3.0T AIR 32CH HNA (January 23, 2026)
  • K223378 — 3.0T 16ch AIR AA (January 3, 2023)
  • K182504 — 3.0T Air MP M, 3.0T Air MP L (October 12, 2018)
  • K180666 — 48CH Head Coil (April 12, 2018)
  • K172695 — AIR Anterior Array, AIR Posterior Array (November 22, 2017)
  • K163205 — 48CH Head Coil (January 12, 2017)
  • K123327 — 1.5T GEM RT OPEN ARRAY (January 11, 2013)
  • K122174 — PEDIATRIC POSITIONER PAD SET (November 16, 2012)
  • K103365 — DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COI (January 12, 2011)
  • K101492 — 8 CHANNEL CARDIAC PHASED ARRAY COIL (June 23, 2010)

Other clearances for product code MOS

  • K252179 — GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Rece (February 10, 2026)
  • 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)
  • K242879 — dS Knee Coil 8ch 1.5T (October 18, 2024)
  • K243033 — dS Wrist coil 8ch 1.5T (October 18, 2024)