Home / 510(k) Clearances / K163528

510(k) K163528

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2017
Date Received
December 16, 2016
Clearance Type
Abbreviated
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.

  • 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)
  • 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)

Other clearances for product code JAK

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)