Integrity™ 1526773
by Elekta Inc.
Integrity 1526773 is a medical device (FDA Class II; FDA product code IYE, Accelerator, linear, medical) made by Elekta Inc., cleared under FDA 510(k) K123808 on 4 Apr 2013 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05060191071079), active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060191071079 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123808 | Date4 Apr 2013 | StatusActive |
Official records
- AccessGUDID record 05060191071079
- FDA 510(k) database K123808
Across registries
- FDA 510(k) K123808 decided 4 Apr 2013 Active
- FDA GUDID UDI-DI 05060191071079 listed 24 Sep 2016 Listed
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
- Listed FDA GUDID 05060191071079
- Recall initiated FDA recalls Z-0723-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integrity™
- Generic name
- Automatic-aperture-control accelerator system collimator
- Model / reference
- 1526773
- Primary DI / UDI-DI
- 05060191071079
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Automatic-aperture-control accelerator system collimator
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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