510(k) K212606
K212606 is an FDA 510(k) premarket notification submitted by Doseoptics, LLC for the device "BeamSite". The FDA issued a decision of Substantially Equivalent on Sep 15, 2021. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Doseoptics, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 15, 2021
- Date Received
- Aug 17, 2021
- Clearance Type
- Special
- 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)