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510(k) K150595

SCENARIA Phase 3 Whole-body X-ray CT System by Hitachi Medical Systems America, Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2015
Date Received
March 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Hitachi Medical Systems America, Inc.

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  • K162079 — TRILLIUM Oval Head Coil 32 (September 16, 2016)
  • 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)
  • 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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