RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
FDA 510(k) K203681 · Brainlab AG
510(k) numberK203681
Submission
- Device name
- RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
- Applicant
- Brainlab AG
Munich, DE - Received
- December 17, 2020
- Decision date
- April 9, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243142 | Cranial 4Pi ImmobilizationIYE · Traditional | 06/23/2025SE |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…MUJ · Traditional | 06/17/2025SE |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…QIH · Traditional | 06/13/2025SE |
| K243810 | TraumaCad Neo (1.1)QIH · Traditional | 06/04/2025SE |
| K242569 | Mixed Reality Spine NavigationSBF · Traditional | 05/16/2025SE |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…HAW · Traditional | 01/28/2025SE |
Questions and answers
When was RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review cleared by the FDA?
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review (K203681) received a 510(k) decision of Substantially Equivalent on April 9, 2021, 113 days after the submission was received.
What is the product code of K203681?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.