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510(k) K212067

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2021
Date Received
July 2, 2021
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 Healthcare Japan Corporation

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  • K203169 — Revolution Ascend (November 20, 2020)
  • K193170 — Deep Learning Image Reconstruction (December 13, 2019)
  • K143345 — SIGNA Pioneer (July 10, 2015)
  • K103327 — DISCOVERY MR750W 3.0T (September 30, 2011)

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