510(k) K180393 ยท JAK System, X-Ray, Tomography, Computed
AIRO Computed Tomography (CT) X-ray System
| Applicant | Mobius Imaging, LLC, Shirley MA, US |
| Decision | Substantially Equivalent, Mar 15, 2018 |
| Received | Feb 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2026 | Mobius Imaging, LLC Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. Open, Classified |
JAK | None listed |
| Jan 9, 2026 | Mobius Imaging, LLC Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System. Open, Classified |
JAK | None listed |
| Jan 17, 2023 | Mobius Imaging, LLC MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. Open, Classified |
JAK | None listed |
| Dec 6, 2022 | Mobius Imaging, LLC MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1 Terminated |
JAK | None listed |
| Aug 1, 2018 | Mobius Imaging, LLC AIRO Mobile CT System
Model # MobiCT-32 Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.