Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator— 510(k) K181404
Substantially EquivalentVarian Medical Systems, Inc.
FDA 510(k) clearance K181404 for Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator, Substantially Equivalent on 2018-06-28. Applicant: Varian Medical Systems, Inc..
Clearance details
- Applicant
- Varian Medical Systems, Inc.
- Product code
- Code IYE
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Palo Alto, CA, US
Adverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . 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.