Brainlab Elements Image Fusion Angio, 1.0

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 04056481138530510(k) K212420

by Brainlab SE

Identity

Trade Name: Brainlab Elements Image Fusion Angio, 1.0 EUDAMED
Brainlab Elements Image Fusion Angio FDA UDI
Generic Name: Radiological PACS software FDA UDI
Device Name: Brainlab Elements Image Fusion Angio EUDAMED
Model / Reference: 04056481138530 EUDAMED
1.0 FDA UDI

Identifiers

Primary DI / UDI-DI: 04056481138530 EUDAMEDFDA UDI
Basic UDI-DI: 4056481FusionAngio6T EUDAMED
Direct Marketing DI: 04056481138530 EUDAMED
510(k) Number: K190042 FDA UDI
K212420 FDA UDI
K223106 FDA UDI
FDA Product Code: LLZ FDA UDI
JAK FDA UDI
EMDN Code: Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term: Radiological PACS software FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
892.1750 FDA UDI
Special Device Type: Software EUDAMED
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Brainlab Elements Image Fusion Angio is a software application designed for the co-registration of cerebrovascular medical image data. It processes and aligns complex vascular datasets to support clinicians during pre-planning phases, particularly in cases where 2D/3D image fusion presents challenges. The device facilitates the definition of vascular objects for treating intracranial vascular structures when used in combination with Elements SmartBrush Angio.

The device is supplied as software and is intended for use in medical imaging environments. It is not sterile, not implantable, and is classified as reusable. The device is subject to Class IIb regulations and has been reviewed under the Radiology advisory committee. It is associated with UDI BASIC_UDI 4056481FusionAngio6T and is authorized under FDA 510(k) and MDR frameworks.

Frequently asked questions

What is Brainlab Elements Image Fusion Angio used for?

It is a software application designed to co-register cerebrovascular medical image data. It aligns complex vascular datasets to support clinicians during pre-planning, especially when 2D/3D image fusion is challenging. It helps define vascular objects for treating intracranial structures when used with Elements SmartBrush Angio.

How is the device supplied and is it sterile?

The device is supplied as software and is intended for use in medical imaging environments. It is not sterile, not implantable, and is classified as reusable. There is no sterilization method associated with it.

Is this a single-use or reusable device?

It is classified as reusable. As a software application, it does not have a physical form that would be discarded after a single use. It is designed for repeated use in clinical settings.

What regulatory framework applies to this device?

It is subject to Class IIb regulations and has been reviewed under the Radiology advisory committee. It is authorized under both FDA 510(k) and MDR frameworks, with a traditional clearance type and substantially equivalent decision.

What is the UDI and reference number for this device?

The device is associated with BASIC_UDI 4056481FusionAngio6T and has a reference number of 04056481138530. The UDI DI data ULID is 01JZ053E8A1BMFRR9P2ZQHK323.

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 Angio (1.0) - physicianaitools.com, Elements: Radiotherapy & Radiosurgery Treatment Planning | Brainlab, Brainlab Elements Image Fusion Review: Pricing, FDA Status ..., Brainlab Elements Image Fusion Angio (K190042) — FDA 510 (k ...

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K212420	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K190042	Class IIb	Active
EUDAMED	European Union	CE/MDR	4056481FusionAngio6T	Class IIb	Active

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Manufacturer

Manufacturer: Brainlab SE
EUDAMED SRN: DE-MF-000006183
FDA Applicant: Brainlab AG

Sources (3)

EUDAMED b8a2b487-5b1f-4350-be17-77364f6afd5a 85 fields · synced Sep 21, 2026
FDA UDI bc8a1c9c-58bb-446e-a72a-463661913787 33 fields · synced May 30, 2026
FDA 510(k) K212420 1 fields · synced Jun 9, 2026