Agility
510(k) K121328
Agility is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Elekta, Ltd., cleared under FDA 510(k) K121328 on 12 Jun 2012, active as of 22 Oct 2026. 3 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 | NumberK121328 | Date12 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K121328
Recalls
-
- Terminated Z-1084-2014
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
-
- Terminated Z-1402-2013
Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
-
- Terminated Z-2340-2012
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
Timeline
- Cleared FDA 510(k) K121328
- Recall initiated FDA recalls Z-2340-2012
- Recall initiated FDA recalls Z-1402-2013
- Recall initiated FDA recalls Z-1084-2014
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- Withdrawn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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