EPIQ Series Diagnostic Ultrasound System
K-Number: K233545 · 2023-11-30
ApplicantPhilips Ultrasound, LLC
Decision Date2023-11-30
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EPIQ Series Diagnostic Ultrasound System is a medical device manufactured by Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2023-11-30 under approval number K233545. 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 System?
EPIQ Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-11-30. It is manufactured by Philips Ultrasound, LLC. The 510(k) number is K233545.
When was EPIQ Series Diagnostic Ultrasound System approved by the FDA?
EPIQ Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2023-11-30, under approval number K233545.
What company makes EPIQ Series Diagnostic Ultrasound System?
EPIQ Series Diagnostic Ultrasound System is manufactured by Philips Ultrasound, LLC.
What is the FDA product code for EPIQ Series Diagnostic Ultrasound System?
The FDA product code for EPIQ Series Diagnostic Ultrasound System is IYN.
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Other Devices by Philips Ultrasound, LLC
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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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.