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FDA 510(k)

PercuNav Image Fusion and Interventional Navigation

K-Number: K201053 · 2020-05-14

ApplicantPhilips Ultrasound, Inc.
Decision Date2020-05-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PercuNav Image Fusion and Interventional Navigation is a medical device manufactured by Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2020-05-14 under approval number K201053. 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 2020-05-14. It is manufactured by Philips Ultrasound, Inc.. The 510(k) number is K201053.

When was PercuNav Image Fusion and Interventional Navigation approved by the FDA?

PercuNav Image Fusion and Interventional Navigation received FDA 510(k) clearance on 2020-05-14, under approval number K201053.

What company makes PercuNav Image Fusion and Interventional Navigation?

PercuNav Image Fusion and Interventional Navigation is manufactured by Philips Ultrasound, Inc..

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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Other Devices by Philips Ultrasound, Inc.

K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System K170716PercuNav Image Fusion and Interventional Navigation K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System K182529Xperius Ultrasound System K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System

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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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