Data / Medical devices / United States / Philips Ultrasound LLC
Philips Ultrasound LLC: FDA-registered device maker in Reedsville, PA, United States, 53 510(k) clearances
Philips Ultrasound LLC is registered with the FDA (registration 2518586) in Reedsville, PA, United States. It lists 7 device types. The FDA files 53 510(k) clearances under its listings, the newest dated September 25, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2518586
- Address
- 1 Echo Dr, Reedsville, PA, United States, 17084
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 19, 1992
- Registered through
- 2026
- Brand names listed
- 21221B (C1914C), 21223B (D5014V), 21228B (D1914V), 21321A (C3540), 21330A (S4), 21350A (S8), 21359A (L7535), 21360A (L5035) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Manufacturer | accessdata.fda.gov |
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| August 4, 2026 | K262311 | Alturion Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| July 27, 2026 | K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 27, 2026 | K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 27, 2026 | K260123 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| March 27, 2026 | K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| December 22, 2025 | K252557 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| October 9, 2025 | K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| July 24, 2025 | K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| June 18, 2025 | K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 21, 2025 | K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 15, 2025 | K242519 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| May 9, 2025 | K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 8, 2025 | K242670 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| April 10, 2025 | K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| February 6, 2025 | K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| December 12, 2024 | K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| November 15, 2024 | K242800 | The 5000 Compact Series Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| November 30, 2023 | K233545 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| October 26, 2023 | K232500 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| May 4, 2023 | K223771 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| September 8, 2021 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| February 23, 2021 | K203406 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 2, 2020 | K202216 | EPIQ Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| May 1, 2020 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 6, 2019 | K192226 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| November 9, 2018 | K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 23, 2018 | K182529 | Xperius Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 27, 2018 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 4, 2017 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| January 10, 2017 | K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| November 16, 2016 | K163020 | Xperius Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| October 3, 2016 | K162549 | Lumify Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| September 14, 2016 | K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| April 6, 2016 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| December 16, 2015 | K153480 | ClearVue850 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| October 30, 2015 | K152899 | Philips Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Healthcare, Inc. | accessdata.fda.gov |
| July 2, 2014 | K141369 | VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| August 21, 2013 | K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| June 18, 2013 | K130499 | IU22 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| December 21, 2012 | K123754 | CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| February 17, 2012 | K120321 | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 24, 2011 | K111513 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| February 1, 2010 | K093563 | IU22 ULTRASOUND SYSTEM AND TRANSDUCERS | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 17, 2009 | K091804 | CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | ITX | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 11, 2008 | K081802 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| June 24, 2008 | K081661 | HD15 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| August 18, 2006 | K062247 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 6, 2005 | K043535 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 4, 2004 | K042540 | PHILIPS IU22 ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 8, 2004 | K034003 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| March 13, 2003 | K030455 | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 7, 2002 | K014191 | M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 | IYN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 5, 2025 | 97643 | Class III | Ongoing | Philips 3D6-2 Ultrasound Transducer | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | accessdata.fda.gov |
| July 3, 2025 | 97217 | Class III | Ongoing | 3D6-2 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | accessdata.fda.gov |
| May 28, 2025 | 96994 | Class II | Ongoing | Philips 3D9-3v Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Automated Radiological Image Processing Software
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.