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510(k) K240850

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2024
Date Received
March 27, 2024
Clearance Type
Special
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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