EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
K-Number: K242020 · 2024-12-12
ApplicantPhilips Ultrasound, LLC
Decision Date2024-12-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System is a medical device manufactured by Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2024-12-12 under approval number K242020. 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; Affiniti Series Diagnostic Ultrasound System?
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2024-12-12. It is manufactured by Philips Ultrasound, LLC. The 510(k) number is K242020.
When was EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System approved by the FDA?
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2024-12-12, under approval number K242020.
What company makes EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System?
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System is manufactured by Philips Ultrasound, LLC.
What is the FDA product code for EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System?
The FDA product code for EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System is IYN.
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Other Devices by Philips Ultrasound, LLC
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K231190EPIQ Series Diagnostic Ultrasound System
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K242800The 5000 Compact Series Ultrasound Systems
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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.