4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)— 510(k) K081036

Substantially Equivalent

Varian Medical Systems, Inc.

FDA 510(k) clearance K081036 for 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS), Substantially Equivalent on 2008-05-09. Applicant: Varian Medical Systems, Inc..

Clearance details

Applicant: Varian Medical Systems, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2008-04-11
Decision date: 2008-05-09
Decision: Substantially Equivalent
Clearance type: Special
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.