BeamSite
510(k) K200940
BeamSite is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Doseoptics, LLC, cleared under FDA 510(k) K200940 on 11 Dec 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200940 | Date11 Dec 2020 | StatusActive |
Official records
- FDA 510(k) database K200940
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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