Home / 510(k) Clearances / K243428

510(k) K243428

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector by Dxtx Medical, Inc. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2025
Date Received
November 5, 2024
Clearance Type
Abbreviated
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 Dxtx Medical, Inc.

  • K223249 — Pro-Tx Endorectal Balloon (PROT-25) (February 10, 2023)

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)
  • 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)
  • K242096 — dS FootAnkle Coil 8ch 1.5T (August 12, 2024)