EchoNavigator R5.0— 510(k) K253614
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K253614 for EchoNavigator R5.0, Substantially Equivalent on 2026-03-17. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Summary
Philips Medical Systems Nederland's EchoNavigator R5.0 is filed under QIH, automated radiological image processing software. The name carries a release designation, R5.0, and the record doesn't describe the software beyond it.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Philips Medical Systems Nederland filed from Best, the Netherlands. Review took 119 calendar days (November 18, 2025 to March 17, 2026).
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Best, NL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.