XIO RADIATION TREATMENT PLANNING SYSTEM— 510(k) K032762

Substantially Equivalent

Computerized Medical Systems, Inc.

FDA 510(k) clearance K032762 for XIO RADIATION TREATMENT PLANNING SYSTEM, Substantially Equivalent on 2003-12-02. Applicant: Computerized Medical Systems, Inc..

Clearance details

Applicant: Computerized Medical Systems, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2003-09-05
Decision date: 2003-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.