RT Elements - Dose Review 2.0
by Brainlab SE
RT Elements - Dose Review 2.0 is a Class II device made by Brainlab SE, cleared under FDA 510(k) K170750 on 24 Aug 2017 and listed in FDA GUDID since 4 Feb 2019 (UDI-DI 04056481140700), active as of 23 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 | GUDID listing | Number04056481140700 | Date4 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170750 | Date24 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 04056481140700
- FDA 510(k) database K170750
Across registries
- FDA 510(k) K170750 decided 24 Aug 2017 Active
- FDA GUDID UDI-DI 04056481140700 listed 4 Feb 2019 Listed
Recalls
-
- Terminated Z-1205-2019
There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.
Timeline
- Cleared FDA 510(k) K170750
- Listed FDA GUDID 04056481140700
- Recall initiated FDA recalls Z-1205-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RT Elements - Dose Review
- Generic name
- Radiation therapy software
- Model / reference
- 2.0
- Primary DI / UDI-DI
- 04056481140700
- 510(k) Number
- FDA product code
- MUJ
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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