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510(k) K160126

AIRO Computed Tomography (CT) X-ray System by Mobius Imaging — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2016
Date Received
January 20, 2016
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 Mobius Imaging

  • K180393 — AIRO Computed Tomography (CT) X-ray System (March 15, 2018)
  • K131431 — AIRO CT SYSTEM (September 26, 2013)

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