Apex
510(k) K111676
Apex is a Class II device made by Elekta Limited, cleared under FDA 510(k) K111676 on 30 Sep 2011, 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 | NumberK111676 | Date30 Sep 2011 | StatusActive |
Official records
- FDA 510(k) database K111676
Recalls
-
- Terminated Z-0885-2013
If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
Timeline
- Cleared FDA 510(k) K111676
- Recall initiated FDA recalls Z-0885-2013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IXI
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5710
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K111676
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 | |||
|---|---|---|---|---|
| Apex™ 1526774 | 1526774 | 05060191071215 | — | On the market |
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