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FDA 510(k)

PercuNav Image Fusion and Interventional Navigation

K-Number: K170716 · 2017-04-21

ApplicantPhilips Ultrasound, Inc.
Decision Date2017-04-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PercuNav Image Fusion and Interventional Navigation is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K170716. 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?

PercuNav Image Fusion and Interventional Navigation is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K170716.

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

PercuNav Image Fusion and Interventional Navigation received FDA 510(k) clearance on 2017-04-21, under 510(k) number K170716.

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

The FDA 510(k) record lists Philips Ultrasound, Inc. 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?

The FDA product code for PercuNav Image Fusion and Interventional Navigation 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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