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510(k) K200477

Flex Body Speeder by Quality Electrodynamics, LLC — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2020
Date Received
February 27, 2020
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, LLC

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  • K242006 — SureWave Elastography (Q7000225) (February 12, 2025)
  • K233652 — Contour Hand/Wrist (Q7000232) (February 16, 2024)
  • K233656 — Contour Shoulder (February 15, 2024)
  • K223429 — Contour Knee (January 13, 2023)
  • 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

  • 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)