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510(k) K121362

1.5T 16CH FLEX SPEEDER LARGE by Neocoil, LLC — Product Code MOS

K121362 is an FDA 510(k) premarket notification submitted by Neocoil, LLC for the device "1.5T 16CH FLEX SPEEDER LARGE". The FDA issued a decision of Substantially Equivalent on June 15, 2012. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Neocoil, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2012
Date Received
May 7, 2012
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 Neocoil, LLC

  • K260947 — 0.55T 12Ch Breast Coil (April 23, 2026)
  • K222407 — 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Co (October 14, 2022)
  • K213687 — 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open (March 11, 2022)
  • K201101 — 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil (June 2, 2020)
  • K182958 — 1.5T 16ch Breast Coil (November 16, 2018)
  • K173409 — Wireless Audio System (February 16, 2018)
  • K173377 — 3.0T 16ch Breast Coil (November 28, 2017)
  • K160350 — ECG CT Gating Device (June 16, 2016)
  • K141832 — 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE (July 31, 2014)
  • K133670 — HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE (July 24, 2014)

Other clearances for product code MOS

  • K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Bre (July 30, 2026)
  • K262294 — dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS H (July 24, 2026)
  • K260947 — 0.55T 12Ch Breast Coil (April 23, 2026)
  • K252587 — HD 8Ch Wrist Array (April 14, 2026)
  • K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Rece (April 1, 2026)
  • K260519 — Smart Fit TorsoCardiac 1.5T (March 20, 2026)
  • 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)

FDA data resources