Elements Viewer
FDA 510(k) K191014 · Brainlab AG
510(k) numberK191014
Submission
- Device name
- Elements Viewer
- Applicant
- Brainlab AG
Munich, DE - Received
- April 17, 2019
- Decision date
- January 23, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
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| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceIYE · Special | 01/14/2026SE |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…LLZ · Special | 10/16/2025SE |
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| 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 |
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Questions and answers
When was Elements Viewer cleared by the FDA?
Elements Viewer (K191014) received a 510(k) decision of Substantially Equivalent on January 23, 2020, 281 days after the submission was received.
What is the product code of K191014?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.