Iplan Rt Image
by Brainlab AG
510(k) K080886
Iplan Rt Image is a medical device (FDA Class II; FDA product code LHN, System, Radiation Therapy, Charged-Particle, Medical) made by Brainlab AG, cleared under FDA 510(k) K080886 on 24 Jun 2008, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080886 | Date24 Jun 2008 | StatusActive |
Official records
- FDA 510(k) database K080886
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LHN
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K080886
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 | |||
|---|---|---|---|---|
| iPlan RT Image 4.1 | 21211F / 4.1 | 04056481000639 | — | On the market |
Similar devices
Other devices filed under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical).
- IBA Proton Therapy System Proteus 235 by Ion Beam Applications S.A.
- Intraoperative Radiation Therapy Devices by General Electric Co.
- Treatment Management System by SIEMENS MEDICAL SOLUTIONS USA, INC.
- ProBeam 360 Proton Therapy System v3.0 by Varian Medical Systems, Inc.
- MODEL 37-185 by Victoreen, Inc.
- Orfit Aerial Couchtop by Orfit Industries NV
- Real Time Image Gating System for Proton Beam Therapy Systems by Hitachi, Ltd., Health Care Company
- Iba Proton Therapy System, Model Proteus 235 by Ion Beam Applications S.A.
- Dose Verification System by Sicel Technologies, Inc.
- PROBEAT by Hitachi, Ltd., Power Systems Group