510(k) K160126 ยท JAK System, X-Ray, Tomography, Computed
AIRO Computed Tomography (CT) X-ray System
| Applicant | Mobius Imaging, Shirley MA, US |
| Decision | Substantially Equivalent, Apr 19, 2016 |
| Received | Jan 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160126
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2017 | Mobius Imaging, LLC AIRO Mobile CT System, Model Number: MobiCT-32
Product Usage:
The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding Terminated |
JAK | None listed |
| Jul 28, 2017 | Brainlab AG AIRO Mobile CT System, Model Number: MobiCT-32
Product Usage:
The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.