Clarity Obp System
by Elekta, Ltd.
510(k) K111332
Clarity Obp System is a Class II device made by Elekta, Ltd., cleared under FDA 510(k) K111332 on 30 Jan 2012, 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 | NumberK111332 | Date30 Jan 2012 | StatusActive |
Official records
- FDA 510(k) database K111332
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- FDA applicant
- Elekta , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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