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510(k) K253173

uCT 780 with uWS-CT-Dual Energy Analysis by Shanghai United Imaging Healthcare Co., Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2026
Date Received
September 26, 2025
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 Shanghai United Imaging Healthcare Co., Ltd.

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  • K252000 — uDR Arria & uDR Aris (November 26, 2025)
  • K252371 — uMR 680 (September 25, 2025)
  • K250045 — uWS-Angio Pro (September 24, 2025)
  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250040 — uWS-Angio (September 12, 2025)
  • K250246 — uMR Jupiter (August 5, 2025)
  • K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)
  • K243547 — uMR Ultra (July 17, 2025)
  • K243397 — uMR 680 (July 16, 2025)

Other clearances for product code JAK

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  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 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)
  • K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S (September 26, 2025)