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.. 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 →
Recalls naming K181404
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181404.
Data sourced from openFDA. This site is unofficial and independent of the FDA.