EPIQ Series Diagnostic Ultrasound Systems
K-Number: K202216 · 2020-09-02
ApplicantPhilips Ultrasound, Inc.
Decision Date2020-09-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EPIQ Series Diagnostic Ultrasound Systems is a medical device manufactured by Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2020-09-02 under approval number K202216. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EPIQ Series Diagnostic Ultrasound Systems?
EPIQ Series Diagnostic Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by Philips Ultrasound, Inc.. The 510(k) number is K202216.
When was EPIQ Series Diagnostic Ultrasound Systems approved by the FDA?
EPIQ Series Diagnostic Ultrasound Systems received FDA 510(k) clearance on 2020-09-02, under approval number K202216.
What company makes EPIQ Series Diagnostic Ultrasound Systems?
EPIQ Series Diagnostic Ultrasound Systems is manufactured by Philips Ultrasound, Inc..
What is the FDA product code for EPIQ Series Diagnostic Ultrasound Systems?
The FDA product code for EPIQ Series Diagnostic Ultrasound Systems is IYN.
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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.