TRON— 510(k) K221230

Name: FDA 510(k) clearance K221230
Creator: U.S. Food and Drug Administration
Published: 2022-07-28

Substantially Equivalent

Xoran Technologies, LLC

FDA 510(k) clearance K221230 for TRON, Substantially Equivalent on 2022-07-28. Applicant: Xoran Technologies, LLC. Device class: 2.

Clearance details

Applicant: Xoran Technologies, LLC
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2022-04-29
Decision date: 2022-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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K261413 — EXTRON 3; EXTRON 62026-08-19
K254205 — Zenition 302026-08-07
K260607 — Shield System (Siemens 30x40)2026-07-31
K253670 — SmartCT (R3.0 (L10))2026-07-10

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Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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 →

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