The following data is part of a premarket notification filed by Mobius Imaging, Llc with the FDA for Airo Computed Tomography (ct) X-ray System.
| Device ID | K180393 |
| 510k Number | K180393 |
| Device Name: | AIRO Computed Tomography (CT) X-ray System |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Mobius Imaging, LLC 2 Shaker Road Shirley, MA 01464 |
| Contact | Norma Lemay |
| Correspondent | Norma Lemay Mobius Imaging, LLC 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 | 2018-02-13 |
| Decision Date | 2018-03-15 |
| Summary: | summary |