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510(k) K233749

Revolution Ascend Sliding by Ge Hangwei Medical Systems Co., Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2024
Date Received
November 22, 2023
Clearance Type
Special
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 Ge Hangwei Medical Systems Co., Ltd.

  • K192956 — Auto Positioning (January 16, 2020)
  • K192686 — Revolution Maxima, Revolution Ace (October 24, 2019)
  • K171013 — Revolution ACT (June 5, 2017)
  • K160131 — OEC Elite MiniView (June 21, 2016)
  • K123596 — OPTIMA CT520 (February 8, 2013)
  • K123417 — BRIVO MR355, OPTIMA MR360 (January 17, 2013)
  • K122694 — GE 8CH FOOT ANKLE COIL (October 25, 2012)
  • K120778 — BRIVO MR355 (March 27, 2012)
  • K103330 — BRIVO MR355, OPTIMA MR360 (February 11, 2011)

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)