Iplan Rt Fibertracking
by Brainlab AG
510(k) K052220
Iplan Rt Fibertracking is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Brainlab AG, cleared under FDA 510(k) K052220 on 30 Sep 2005, 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 | NumberK052220 | Date30 Sep 2005 | StatusActive |
Official records
- FDA 510(k) database K052220
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- Withdrawn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
Similar devices
Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).
- MRIdian Linac System with 138-leaf Collimator by VIEWRAY INCORPORATED
- ClearCheck Model RADCC V2 by Radformation, Inc.
- Pron Pillo PP 116800 by MACROMEDICS B.V.
- Wall holder for WS P10107-446 by IT-V Medizintechnik GmbH
- CLINAC 2500 by Varian Assoc., Inc.
- 6MV PORT FILM CAPABILITY OPTION by Varian Assoc., Inc.
- COREGISTRATION FUNCTION by Nomos Corp.
- LINAC-BASED STEROTACTIC RADIOSURGERY by Radionics Software Applications, Inc.
- MODIFICATION TO: ON-BOARD IMAGER DEVICE by Varian Medical Systems, Inc.
- KLARITY MEDICAL R550-CAEP by Klarity Medical Products, LLC