510(k) K203722
K203722 is an FDA 510(k) premarket notification submitted by Micropos Medical AB for the device "RayPilot System". The FDA issued a decision of Substantially Equivalent on Sep 2, 2021. 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 2, 2021
- Date Received
- Dec 21, 2020
- 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)