Brainlab Elements Image Fusion, Contouring (4.5) +4 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223106

Identifiers

510(k) Number: K223106 FDA 510(k)
FDA Product Code: QIH FDA 510(k)
Models / Variants: Brainlab Elements Image Fusion, Contouring (4.5) FDA 510(k)EUDAMED
Image Fusion (4.5) FDA 510(k)EUDAMED
Fibertracking (2.0) FDA 510(k)EUDAMED
BOLD MRI Mapping (1.0) FDA 510(k)EUDAMED
Image Fusion Angio (1.0) FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.2050 FDA 510(k)
Regulation Number: 892.2050 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Brainlab Elements Image Fusion, Contouring (4.5); Image Fusion (4.5); Fiber Tracking (2.0); BOLD MRI Mapping (1.0); and Image Fusion Angio (1.0) are software applications designed for advanced medical imaging and neurosurgical planning. These tools enable multi-modal image fusion, including MRI, CT, and angiographic data, to enhance precision in radiotherapy, radiosurgery, and stereotactic procedures. Fiber Tracking (2.0) visualizes white matter tracts, while BOLD MRI Mapping (1.0) analyzes functional MRI data for task-based activation mapping. Image Fusion Angio (1.0) facilitates co-registration of cerebrovascular imaging for improved vascular planning.

The software is supplied as a standalone or integrated component within Brainlab’s Elements platform, intended for use in clinical settings by trained professionals. It operates on compatible workstations and requires no physical sterilization, as it is a digital solution. The device is classified under the Medical Device Regulation (MDR) and holds FDA 510(k) clearance (K223106) as substantially equivalent to a predicate device. No specific sterility or single-use requirements are noted, and MRI safety compliance is implied by its integration with MRI-compatible imaging modalities.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5 ..., Elements: Radiotherapy & Radiosurgery Treatment Planning | Brainlab, Brainlab Elements Image Fusion, Contouring… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K223106	Class II	Active

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Manufacturer

Manufacturer: Brainlab AG

Sources (2)

FDA 510(k) K223106 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026