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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K180393
Device Name AIRO Computed Tomography (CT) X-ray System
Applicant
Mobius Imaging, LLC
2 Shaker Road
Shirley,  MA  01464
Applicant Contact Norma LeMay
Correspondent
Mobius Imaging, LLC
2 Shaker Road
Shirley,  MA  01464
Correspondent Contact Norma LeMay
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/13/2018
Decision Date 03/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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