K254265
- 510(k) number
- K254265
- Device name
- Helion Viewer Suite
- Applicant
- Videomed Srl ( a Baxter Healthcare Corp company) IT
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-05-27
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K254265.pdf
Official FDA record: K254265
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.