The following data is part of a premarket notification filed by Mobius Imaging with the FDA for Airo Computed Tomography (ct) X-ray System.
Device ID | K160126 |
510k Number | K160126 |
Device Name: | AIRO Computed Tomography (CT) X-ray System |
Classification | System, X-ray, Tomography, Computed |
Applicant | Mobius Imaging 2 Shaker Road Shirley, MA 01464 |
Contact | Norma J Lemay |
Correspondent | Norma J Lemay Mobius Imaging 2 Shaker Road Shirley, MA 01464 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-20 |
Decision Date | 2016-04-19 |
Summary: | summary |