ON-BOARD IMAGER DEVICE— 510(k) K042720
Substantially EquivalentVarian Medical Systems
FDA 510(k) clearance K042720 for ON-BOARD IMAGER DEVICE, Substantially Equivalent on 2004-10-29. Applicant: Varian Medical Systems. Device class: 2.
Clearance details
- Applicant
- Varian Medical Systems
- 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
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 K042720
K-number listed on FDA's recall record- Z-0526-2015 — Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
- Z-1502-2014 — On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042720.
Data sourced from openFDA. This site is unofficial and independent of the FDA.