Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
FDA 510(k) K243633 · Brainlab AG
Submission
- Device name
- Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
- Applicant
- Brainlab AG
Munich, DE - Received
- November 25, 2024
- Decision date
- June 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Other 510(k)s with product code QIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
More from Lucida Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K252562 | Spine & Trauma Navigation InstrumentsOLO · Special | 09/12/2025SE |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PADOWB · Traditional | 07/22/2025SE |
| 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 |
| 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 |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceIYE · Traditional | 07/24/2024SE |
Questions and answers
When was Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) cleared by the FDA?
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) (K243633) received a 510(k) decision of Substantially Equivalent on June 13, 2025, 200 days after the submission was received.
What is the product code of K243633?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.