AIRO Computed Tomography (CT) X-ray System— 510(k) K180393
Substantially EquivalentMobius Imaging, LLC
FDA 510(k) clearance K180393 for AIRO Computed Tomography (CT) X-ray System, Substantially Equivalent on 2018-03-15. Applicant: Mobius Imaging, LLC. Device class: 2.
Clearance details
- Applicant
- Mobius Imaging, LLC
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shirley, MA, US
Recent devices under product code JAK
view allMore clearances from Mobius Imaging, LLC
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K180393
K-number listed on FDA's recall record- Z-1040-2026 — Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
- Z-1041-2026 — Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
- Z-0957-2023 — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
- Z-0344-2023 — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
- Z-2991-2018 — AIRO Mobile CT System Model # MobiCT-32
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180393.
Data sourced from openFDA. This site is unofficial and independent of the FDA.