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510(k) K171013

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2017
Date Received
April 4, 2017
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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  • 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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