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510(k) K213766

dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T by Invivo Corporation — Product Code MOS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 23, 2021
Date Received: December 1, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

Device Classification

Device Name: Coil, Magnetic Resonance, Specialty
Device Class: Class II
Regulation Number: 892.1000
Review Panel: RA
Submission Type

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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)
K133030 — DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) (January 22, 2014)

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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)