510(k) K182138
K182138 is an FDA 510(k) premarket notification submitted by Eleckta Limited for the device "Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD". The FDA issued a decision of Substantially Equivalent on Sep 5, 2018. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 5, 2018
- Date Received
- Aug 7, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)