510(k) K254265
K254265 is an FDA 510(k) premarket notification submitted by Videomed Srl ( a Baxter Healthcare Corp company) for the device "Helion Viewer Suite". The FDA issued a decision of Substantially Equivalent on May 27, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2026
- Date Received
- December 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type