Clearance Summary
Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD received FDA 510(k) clearance under submission number K182138, sponsored by Eleckta Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-09-05.
- Submission: K182138
- Applicant / Sponsor: Eleckta Limited
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2018-09-05
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.