Desktop Pro
by Elekta, Ltd.
510(k) K080585
Desktop Pro is a Class II device made by Elekta, Ltd., cleared under FDA 510(k) K080585 on 11 Jun 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 | NumberK080585 | Date11 Jun 2008 | StatusActive |
Official records
- FDA 510(k) database K080585
Recalls
-
- Terminated Z-1082-2014
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) K080585
- Recall initiated FDA recalls Z-1082-2014
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- Withdrawn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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