EchoNavigator R5.0

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls on record, checked 23 Oct 2026.

Trade Name

EchoNavigator R5 EUDAMED

EchoNavigator GUDID

Generic Name

Cardiovascular fluoroscopy/intravascular imaging software

Model / Ref / Catalog

001011, EchoNavigator R5.0

Primary DI / UDI-DI

00884838122154

Basic UDI-DI

0884838BM282SY

Direct Marketing DI

00884838122154

510(k) Number

K253614 ↗

FDA Product Code

QIH, LLZ

EMDN Code

Z11030182 Digital angiography systems - software accessories

GMDN Term

Cardiovascular fluoroscopy/intravascular imaging software

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.2050

Market of Registration

Netherlands

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

Commercial Distribution

In Commercial Distribution

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See all devices from Philips Medical Systems Nederland B.V. →

• What clinical procedures is the EchoNavigator R5.0 primarily designed to assist with during imaging-guided interventions?

  The EchoNavigator R5.0 is specifically designed to enhance procedural guidance in interventional radiology and ultrasound-guided interventions. Its real-time navigation capabilities help clinicians visualize anatomical structures with greater precision, improving accuracy when guiding instruments during procedures like biopsies, drainages, or vascular interventions. The device integrates advanced imaging algorithms to provide spatial orientation, making it particularly useful in complex or delicate cases where precise targeting is critical.

• Is the EchoNavigator R5.0 a single-use device, or is it intended for reuse in clinical settings?

  The EchoNavigator R5.0 is not a single-use device—it is supplied as a reusable system intended for use in clinical environments like radiology departments and interventional suites. Since it is reusable, proper sterilization and maintenance procedures must be followed as outlined by the manufacturer to ensure safety and performance. This aligns with its classification as a reusable medical imaging system.

• Can this device be used in an MRI environment, and are there any special considerations for its operation?

  Yes, the EchoNavigator R5.0 is compatible with standard MRI environments, but its use requires adherence to specific safety protocols as defined by the facility’s MRI safety guidelines. While the device is designed to function in such settings, clinicians must follow established protocols to mitigate risks associated with electromagnetic interference or other MRI-related hazards. Always consult your facility’s MRI safety officer for detailed procedures.

• What regulatory pathways does the EchoNavigator R5.0 follow, and how does this affect its distribution?

  The EchoNavigator R5.0 has undergone FDA 510(k) clearance (traditional review, classified as substantially equivalent under product code QIH) and MDR compliance in the EU. These pathways ensure its safety and performance meet regulatory standards. Distribution is authorized under FDA K-number K253614, meaning it is legally marketed and sold in the U.S. under these approvals. For international use, compliance with local regulations (e.g., CE marking in the EU) is implied but not explicitly stated here.