Agility
510(k) K123808
Agility is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Elekta, Ltd., cleared under FDA 510(k) K123808 on 4 Apr 2013, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123808 | Date4 Apr 2013 | StatusActive |
Official records
- FDA 510(k) database K123808
Recalls
-
- Terminated Z-0723-2018
Potential for positional errors following automatic table movement (ATM).
-
- Terminated Z-1085-2014
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Timeline
- Cleared FDA 510(k) K123808
- Recall initiated FDA recalls Z-1085-2014
- Recall initiated FDA recalls Z-0723-2018
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- Withdrawn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 K123808
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 | |||
|---|---|---|---|---|
| Integrity™ 1526773 | 1526773 | 05060191071079 | — | On the market |
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