MINICAT— 510(k) K113421

Name: FDA 510(k) clearance K113421
Creator: U.S. Food and Drug Administration
Published: 2012-07-11

Substantially Equivalent

Xoran Technologies, Inc.

FDA 510(k) clearance K113421 for MINICAT, Substantially Equivalent on 2012-07-11. Applicant: Xoran Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Xoran Technologies, Inc.
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2011-11-18
Decision date: 2012-07-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAK

view all

K253836 — FCT iStream Phase 22026-09-04
K253450 — BodyTom Elite (NL4000)2026-07-28
K253770 — CardIQ Suite2026-07-21
K253560 — Enhanced Boundary for PCCT2026-06-24
K253026 — Respiratory Gating for Scanners (2.1)2026-06-04

More clearances from Xoran Technologies, Inc.

view all

K073306 — XORANCONNECT2008-01-07
K061834 — XCAT; XCAT FOR NEURO2006-08-07
K032243 — MINICAT DENTOCAT2003-10-02

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 K113421

K-number listed on FDA's recall record

Z-1210-2015 — Xoran MiniCAT X-ray imaging deviceClass II·Terminated·Xoran Technologies, LLC·20140908

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113421.

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