MLCI2
by Elekta, Ltd.
510(k) K082122
MLCI2 is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Elekta, Ltd., cleared under FDA 510(k) K082122 on 29 Aug 2008, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082122 | Date29 Aug 2008 | StatusActive |
Official records
- FDA 510(k) database K082122
Recalls
-
- Terminated Z-1651-2012
The Y2 diaphragm block was found loose.
Timeline
- Cleared FDA 510(k) K082122
- Recall initiated FDA recalls Z-1651-2012
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- Withdrawn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 K082122
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 | |||
|---|---|---|---|---|
| MLCi2™ 1525724 | 1525724 | 05060191071024 | — | On the market |
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