Exactrac 5.5
by Brainlab AG
510(k) K072506
Exactrac 5.5 is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Brainlab AG, cleared under FDA 510(k) K072506 on 26 Oct 2007, 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 | NumberK072506 | Date26 Oct 2007 | StatusActive |
Official records
- FDA 510(k) database K072506
Recalls
-
- Terminated Z-1707-2014
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
Timeline
- Cleared FDA 510(k) K072506
- Recall initiated FDA recalls Z-1707-2014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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