AIRO Computed Tomography (CT) X-ray System— 510(k) K160126
Substantially EquivalentMobius Imaging
FDA 510(k) clearance K160126 for AIRO Computed Tomography (CT) X-ray System, Substantially Equivalent on 2016-04-19. Applicant: Mobius Imaging. Device class: 2.
Clearance details
- Applicant
- Mobius Imaging
- 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 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 K160126
K-number listed on FDA's recall record- Z-0715-2018 — 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 pediatric patients and patients weighing over 400 lbs. (182 kg).
- Z-0509-2018 — 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 pediatric patients and patients weighing over 400 lbs. (182 kg).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160126.
Data sourced from openFDA. This site is unofficial and independent of the FDA.