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510(k) K162079

TRILLIUM Oval Head Coil 32 by Hitachi Medical Systems America, Inc. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2016
Date Received
July 27, 2016
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 Hitachi Medical Systems America, Inc.

  • K163528 — HITACHI Supria Whole-body X-ray CT System Phase 3 (March 3, 2017)
  • K161748 — SUPRIA w/guideShot Option (August 17, 2016)
  • K160152 — Trillium Oval V 5.1 MRI System (May 20, 2016)
  • K153547 — ECHELON Oval V 5.1 MRI System (March 31, 2016)
  • K150595 — SCENARIA Phase 3 Whole-body X-ray CT System (October 30, 2015)
  • K150565 — Supria Whole-body X-ray CT System (September 30, 2015)
  • K151015 — ECHELON Oval V 5.0 MRI System (July 29, 2015)
  • K143537 — Sirius Starmobile tiara (March 6, 2015)
  • K142734 — TRILLIUM Oval MR System (March 2, 2015)
  • K123509 — SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM (March 29, 2013)

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  • 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)