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510(k) K192956

Auto Positioning by Ge Hangwei Medical Systems Co., Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2020
Date Received
October 21, 2019
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 Ge Hangwei Medical Systems Co., Ltd.

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  • 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

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  • 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)
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  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)