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510(k) K220961

Deep Learning Image Reconstruction by Ge Healthcare Japan Corporation — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2022
Date Received
April 1, 2022
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

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  • K143345 — SIGNA Pioneer (July 10, 2015)
  • K103327 — DISCOVERY MR750W 3.0T (September 30, 2011)

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