BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)— 510(k) K103394

Substantially Equivalent

Varian Medical Systems, Oncology Systems

FDA 510(k) clearance K103394 for BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV), Substantially Equivalent on 2011-01-12. Applicant: Varian Medical Systems, Oncology Systems.

Clearance details

Applicant: Varian Medical Systems, Oncology Systems
Product code: Code IYE
Advisory panel: Radiology
Date received: 2010-11-19
Decision date: 2011-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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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.