IPLAN RT DOSE— 510(k) K053584
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K053584 for IPLAN RT DOSE, Substantially Equivalent on 2006-07-12. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Applicant
- Brainlab AG
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Heimstetten, DE
Recent devices under product code MUJ
view allMore clearances from Brainlab AG
view allRecalls naming K053584
K-number listed on FDA's recall record- Z-0956-2015 — iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
- Z-0957-2015 — iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053584.
Data sourced from openFDA. This site is unofficial and independent of the FDA.