EchoNavigator

by Philips Medical Systems Nederland B.V. Netherlands EUDAMED510(k)GUDID

Ref 001011510(k) K221270

Product code LLZEMDN Z11030182

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00884838059283 Basic UDI-DI	Date25 Nov 2024Registered	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Special	NumberK221270	Date31 May 2022Cleared	StatusActive
United States	GUDID listing GUDID	Number00884838059283 UDI-DI	Date24 Sep 2016Listed	StatusListed

Coverage

2 jurisdictions

Active
Expiring (legacy directive)
Not covered

United States FDA 510(k) Active
European Union CE/MDD Expiring (legacy directive)

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Generic Name: Cardiovascular fluoroscopy/intravascular imaging software
Model / Ref / Catalog: 001011, EchoNavigator - 2

Primary DI / UDI-DI: 00884838059283
Basic UDI-DI: B-00884838059283
510(k) Number: K221270
FDA Product Code: LLZ
EMDN Code: Z11030182 Digital angiography systems - software accessories
GMDN Term: Cardiovascular fluoroscopy/intravascular imaging software

Device Class: Class IIa EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 892.2050
Special Device Type: -1192
Market of Registration: Netherlands
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent
Commercial Distribution: Not in Commercial Distribution

Truth per registry

3 sources · 2 fields differ

Field	EUDAMED	510(k)	GUDID
Model / Reference	EUDAMED 001011	510(k) n/a	GUDID EchoNavigator - 2
Device Class	EUDAMED Class IIa	510(k) Class II	GUDID Class II

Manufacturer details

EUDAMED SRN: NL-MF-000001489

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Properties & raw data

Show properties, registry sources and raw records

Prescription Use
Lot / Batch Number

Other properties (22)

Sterile: No
Single Use: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No

Sources (3)

EUDAMED 3162f5d1-3f99-4d5d-8187-9cbcb1822be4 61 fields · synced 24 Oct 2026
FDA 510(k) K221270 24 fields · synced 18 May 2026
FDA UDI f5d66a92-cd8c-46c5-b814-1d6dda81c820 35 fields · synced 30 May 2026