Home / 510(k) Clearances / K111673

510(k) K111673

1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL by Invivo Corporation — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2011
Date Received
June 15, 2011
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 Invivo Corporation

  • K213766 — dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5 (December 23, 2021)
  • K212227 — Philips MR Patient Care Portal (September 30, 2021)
  • K212175 — DynaCAD (August 2, 2021)
  • K193403 — UroNav System (December 27, 2019)
  • K192200 — DynaCAD (October 9, 2019)
  • K182561 — UroNav (Version 3.0) (October 19, 2018)
  • K162177 — dS FootAnkle I6CH 1.5T Coil (September 14, 2016)
  • K162001 — 1.5T and 3.0T 16 CH GE Shoulder Coils (August 31, 2016)
  • K152330 — Expression MR400 MRI Patient Monitoring System (December 23, 2015)
  • K153073 — UroNav (Version 2.0) (November 16, 2015)

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)