ExacTrac Dynamic
510(k) K220338
ExacTrac Dynamic is a Class II device made by Brainlab AG, cleared under FDA 510(k) K220338 on 29 Apr 2022, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220338 | Date29 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K220338
Recalls
-
- Ongoing Z-1259-2023
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Timeline
- Cleared FDA 510(k) K220338
- Recall initiated FDA recalls Z-1259-2023
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- Withdrawn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
Devices cleared under K220338
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 | |||
|---|---|---|---|---|
| ExacTrac Dynamic 1.1 | 1.1 | 04056481143978 | — | No longer on the market |