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510(k) K180393

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2018
Date Received
February 13, 2018
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, LLC

  • K160126 — AIRO Computed Tomography (CT) X-ray System (April 19, 2016)
  • K131431 — AIRO CT SYSTEM (September 26, 2013)

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