Clearance Summary
Helion Viewer Suite received FDA 510(k) clearance under submission number K254265, sponsored by Videomed Srl ( a Baxter Healthcare Corp company). The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-05-27.
- Submission: K254265
- Applicant / Sponsor: Videomed Srl ( a Baxter Healthcare Corp company)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2026-05-27
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.