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 a medical device manufactured by Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2023-01-18 under approval 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. It is manufactured by Philips Ultrasound, LLC. The 510(k) number is K223804.
When was PercuNav Image Fusion and Interventional Navigation System approved by the FDA?
PercuNav Image Fusion and Interventional Navigation System received FDA 510(k) clearance on 2023-01-18, under approval number K223804.
What company makes PercuNav Image Fusion and Interventional Navigation System?
PercuNav Image Fusion and Interventional Navigation System is manufactured by Philips Ultrasound, LLC.
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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Other Devices by Philips Ultrasound, LLC
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K231190EPIQ Series Diagnostic Ultrasound System
K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
K242800The 5000 Compact Series Ultrasound Systems
K240980EPIQ Series Diagnostic Ultrasound System
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Official Source
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