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510(k) K244054

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) by Quality Electrodynamics — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2025
Date Received
December 31, 2024
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 Quality Electrodynamics

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  • K223429 — Contour Knee (January 13, 2023)
  • K200477 — Flex Body Speeder (April 8, 2020)
  • K193140 — Flex Body SPEEDER (January 3, 2020)
  • K183111 — Contour 24 (December 7, 2018)
  • K181697 — 16ch Foot/ Ankle SPEEDER (July 11, 2018)
  • K173469 — 16ch T/R Hand Wrist Coil (January 9, 2018)
  • K173446 — Contour 24 (November 17, 2017)

Other clearances for product code MOS

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  • 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)
  • 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)