K253026
- 510(k) number
- K253026
- Device name
- Respiratory Gating for Scanners (2.1)
- Applicant
- Varian Medical Systems, Inc. CA · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2026-06-04
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253026.pdf
Official FDA record: K253026
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.