The following data is part of a premarket notification filed by Mobius Imaging, Llc with the FDA for Airo Ct System.
| Device ID | K131431 |
| 510k Number | K131431 |
| Device Name: | AIRO CT SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | MOBIUS IMAGING, LLC 323 WEST MAIN STREET Ayer, MA 01432 |
| Contact | Norma Lemay |
| Correspondent | Norma Lemay MOBIUS IMAGING, LLC 323 WEST MAIN STREET Ayer, MA 01432 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-17 |
| Decision Date | 2013-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869346000200 | K131431 | 000 |