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FDA 510(k)

PercuNav Image Fusion and Interventional Navigation System

K-Number: K223804 · 2023-01-18

ApplicantPhilips Ultrasound, LLC
Decision Date2023-01-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PercuNav Image Fusion and Interventional Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2023-01-18 under 510(k) number K223804. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PercuNav Image Fusion and Interventional Navigation System?

PercuNav Image Fusion and Interventional Navigation System is a medical device that received FDA 510(k) clearance on 2023-01-18. The listed applicant is Philips Ultrasound, LLC. The 510(k) number is K223804.

When did PercuNav Image Fusion and Interventional Navigation System receive FDA 510(k) clearance?

PercuNav Image Fusion and Interventional Navigation System received FDA 510(k) clearance on 2023-01-18, under 510(k) number K223804.

Who is the listed applicant for PercuNav Image Fusion and Interventional Navigation System?

The FDA 510(k) record lists Philips Ultrasound, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PercuNav Image Fusion and Interventional Navigation System?

The FDA product code for PercuNav Image Fusion and Interventional Navigation System is JAK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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