ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)— 510(k) K221448
Substantially EquivalentVarian Medical Systems, Inc.
FDA 510(k) clearance K221448 for ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8), Substantially Equivalent on 2022-06-15. Applicant: Varian Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Varian Medical Systems, Inc.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Palo Alto, CA, US
Recent devices under product code IYE
view allMore clearances from Varian Medical Systems, Inc.
view allAdverse 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.