510(k) K131431 ยท JAK System, X-Ray, Tomography, Computed
AIRO CT SYSTEM
| Applicant | Mobius Imaging, LLC, Ayer MA, US |
| Decision | Substantially Equivalent, Sep 26, 2013 |
| Received | May 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2015 | Mobius Imaging, LLC Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.