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510(k) K243794

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound, LLC — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2025
Date Received
December 10, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • K242670 — Lumify Diagnostic Ultrasound System (May 8, 2025)
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