Clarity
510(k) K141855
Clarity is a Class II device made by Elekta, Ltd., cleared under FDA 510(k) K141855 on 8 Oct 2014, 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 | NumberK141855 | Date8 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K141855
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- Withdrawn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
Devices cleared under K141855
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Clarity® 1531854 | 1531854 | 07540180000191 | No longer on the market | |
| Clarity® 9310-00042 | 9310-00042 | 07540180000184 | On the market | |
| Clarity® 9310-00043 | 9310-00043 | 07540180000207 | On the market |
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