Iplan Rt
by Brainlab AG
510(k) K103246
Iplan Rt is a medical device (FDA Class II; FDA product code MUJ, System, Planning, Radiation Therapy Treatment) made by Brainlab AG, cleared under FDA 510(k) K103246 on 16 Mar 2011, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103246 | Date16 Mar 2011 | StatusActive |
Official records
- FDA 510(k) database K103246
Recalls
-
- Terminated Z-0957-2015
- Terminated Z-0956-2015
iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
Timeline
- Cleared FDA 510(k) K103246
- Recall initiated FDA recalls Z-0957-2015
- Recall initiated FDA recalls Z-0956-2015
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUJ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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