iPlan RT Image 4.1
by Brainlab SE
iPlan RT Image 4.1 (21211F) is a radiation therapy software (FDA Class II; FDA product code LHN, System, Radiation Therapy, Charged-Particle, Medical) made by Brainlab SE, cleared under FDA 510(k) K080886 on 24 Jun 2008 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 04056481000639), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04056481000639 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080886 | Date24 Jun 2008 | StatusActive |
Official records
- AccessGUDID record 04056481000639
- FDA 510(k) database K080886
Across registries
- FDA 510(k) K080886 decided 24 Jun 2008 Active
- FDA GUDID UDI-DI 04056481000639 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K080886
- Listed FDA GUDID 04056481000639
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iPlan RT Image
- Generic name
- Radiation therapy software
- Model / Ref / Catalog
- 4.1, 21211F
- Primary DI / UDI-DI
- 04056481000639
- 510(k) Number
- FDA product code
- LHN
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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