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510(k) K122646

DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T by Invivo Corporation — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2012
Date Received
August 30, 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 Invivo Corporation

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  • 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)

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  • K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) (October 20, 2025)
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  • 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)