XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM— 510(k) K033066

Name: FDA 510(k) clearance K033066
Creator: U.S. Food and Drug Administration
Published: 2003-11-12

Substantially Equivalent

Xitec Holdings, LLC

FDA 510(k) clearance K033066 for XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM, Substantially Equivalent on 2003-11-12. Applicant: Xitec Holdings, LLC. Device class: 2.

Clearance details

Applicant: Xitec Holdings, LLC
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2003-09-29
Decision date: 2003-11-12
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.