AIRO CT SYSTEM— 510(k) K131431

Name: FDA 510(k) clearance K131431
Creator: U.S. Food and Drug Administration
Published: 2013-09-26

Substantially Equivalent

Mobius Imaging, LLC

FDA 510(k) clearance K131431 for AIRO CT SYSTEM, Substantially Equivalent on 2013-09-26. 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: 2013-05-17
Decision date: 2013-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K131431

K-number listed on FDA's recall record

Z-1016-2015 — Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.Class II·Terminated·Mobius Imaging, LLC·20141208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131431.

Data sourced from openFDA. This site is unofficial and independent of the FDA.