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510(k) K123596

OPTIMA CT520 by Ge Hangwei Medical Systems Co., Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2013
Date Received
November 21, 2012
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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  • K160131 — OEC Elite MiniView (June 21, 2016)
  • 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)

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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)