Nano4Imaging

Company overview

Nano4Imaging is a Düsseldorf, Germany medical device company founded in 2011 and led by co-founder and CEO Rudolf Schulze Vohren. Its work combines guidewire design, imaging markers and navigation software for procedures performed under MRI guidance.

The EmeryGlide family comprises metal-free guidewires intended to introduce and position diagnostic or interventional devices. The company labels the guidewires MR Conditional: their use depends on specified MRI conditions rather than an unrestricted claim of MRI safety.

Nano4Imaging is also developing and presenting trackr.ai navigation software for image-guided interventions. Its EU-funded TRACKR project supported that platform’s development. The guidewire clearances and the software’s regulatory position must be considered separately.

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Products & regulatory status How does MedTechIndex get this information?

Summary

FDA records identify three guidewire clearances: K160594, K173423 and K253262. These records concern MR Wire and EmeryGlide configurations; MR Conditional labeling requires compliance with the relevant scanning conditions. ^[1][6][7][8]

The trackr.ai software is a distinct part of the company’s portfolio. The guidewire clearances do not authorize every software function, catheter or clinical application described in the broader TRACKR development programme. ^[1][6][7][8]

Regulatory snapshot How to read this snapshot

U.S. FDA

3+

510(k) clearances

—

De Novo grants

—

PMA approvals

—

Recall events

Latest recorded source review: 2026-11-05.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

MR-conditional vascular guidewire

EmeryGlide / MR Wire guidewire family ↗

Metal-free guidewire family for introduction and placement of diagnostic or interventional devices under specified MR conditions. U.S. records cover earlier MR Wire configurations and a later EmeryGlide model. ^[1][6][7][8]

Commercial · Selected U.S. guidewire clearances verified

Commercial development

MRI interventional navigation software

trackr.ai navigation platform ↗

Image-based navigation platform combining MRI-compatible devices with software for real-time catheter visualization and procedural guidance. The guidewire clearances do not establish a separate software clearance. ^[1]

Navigation platform · U.S. authorization not established