FDA 510(k) Applications Submitted by Philips Ultrasound LLC

FDA 510(k) Number Submission Date Device Name Applicant
K242020 07/11/2024 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Philips Ultrasound LLC
K231190 04/26/2023 EPIQ Series Diagnostic Ultrasound System Philips Ultrasound LLC
K223804 12/19/2022 PercuNav Image Fusion and Interventional Navigation System Philips Ultrasound LLC
K250886 03/25/2025 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems Philips Ultrasound LLC
K243793 12/10/2024 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Philips Ultrasound LLC
K243794 12/10/2024 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Philips Ultrasound LLC
K250030 01/06/2025 Flash Ultrasound System 5100 Point of Care Philips Ultrasound LLC
K240850 03/27/2024 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems Philips Ultrasound LLC
K240980 04/10/2024 EPIQ Series Diagnostic Ultrasound System Philips Ultrasound LLC
K233545 11/03/2023 EPIQ Series Diagnostic Ultrasound System Philips Ultrasound LLC
K233788 11/28/2023 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System Philips Ultrasound LLC
K251455 05/12/2025 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Philips Ultrasound LLC
K241659 06/10/2024 Ultrasound Workspace (UWS 6.0) Philips Ultrasound LLC
K222648 09/01/2022 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) Philips Ultrasound LLC
K242800 09/17/2024 The 5000 Compact Series Ultrasound Systems Philips Ultrasound LLC
K250177 01/22/2025 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Philips Ultrasound LLC
K251110 04/11/2025 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems Philips Ultrasound LLC


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